User login
Care gaps common after anal sphincter injuries from childbirth
Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.
In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.
“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”
The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.
Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.
For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.
Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.
Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.
However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.
Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.
The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.
Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
Not asked, not told
Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.
“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.
Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.
Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.
Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.
Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.
In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.
“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”
The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.
Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.
For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.
Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.
Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.
However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.
Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.
The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.
Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
Not asked, not told
Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.
“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.
Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.
Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.
Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.
Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.
In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.
“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”
The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.
Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.
For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.
Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.
Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.
However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.
Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.
The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.
Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
Not asked, not told
Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.
“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.
Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.
Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.
Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.
Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AUGS 2022
Nonhormonal drug for menopause symptoms passes phase 3 test
A phase 3 trial has associated the neurokinin-3 (NK3)–receptor inhibitor fezolinetant, an oral therapy taken once daily, with substantial control over the symptoms of menopause, according to results of the randomized SKYLIGHT 2 trial.
The nonhormonal therapy has the potential to address an important unmet need, Genevieve Neal-Perry, MD, PhD, said at the annual meeting of the Endocrine Society.
The health risks of hormone therapy (HT) have “caused quite a few women to consider whether hormone replacement is right for them, and, in addition, there are other individuals who have hormone-responsive cancers or other disorders that might prohibit them [from using HT],” Dr. Neal-Perry said.
The NK3 receptor stimulates the thermoregulatory center in the hypothalamus. By blocking the NK3 receptor, vasodilation and other downstream effects are inhibited, explained Dr. Neal-Perry. She credited relatively recent advances in understanding the mechanisms of menopausal symptoms for identifying this and other potentially targetable mediators.
SKYLIGHT 2 trial: Two phases
In the double-blind multinational phase 3 SKYLIGHT 2 trial, 484 otherwise healthy symptomatic menopausal women were randomized to 30 mg of fezolinetant, 45 mg of fezolinetant, or placebo. The 120 participating centers were in North American and Europe.
In the first phase, safety and efficacy were evaluated over 12 weeks. In a second extension phase, placebo patients were rerandomized to one of the fezolinetant study doses. Those on active therapy remained in their assigned groups. All patients were then followed for an additional 40 weeks.
The coprimary endpoints were frequency and severity of moderate to severe vasomotor symptoms as reported by patients using an electronic diary. There were several secondary endpoints, including patient-reported outcomes regarding sleep quality.
As expected from other controlled trials, placebo patients achieved about a 40% reduction in moderate to severe vasomotor symptom frequency over the first 12 weeks. Relative to placebo, symptom frequency declined more quickly and steeply on fezolinetant. By week 12, both achieved reductions of about 60%. Statistical P values for the differences in the three arms were not provided, but Dr. Neal-Perry reported they were significant.
Vasomotor severity, like frequency, is reduced
The change in vasomotor severity, which subjects in the trial rated as better or worse, was also significant. The differences in the severity curves were less, but they separated in favor of the two active treatment arms by about 2 weeks, and the curves continued to show an advantage for fezolinetant over both the first 12 weeks and then the remaining 40 weeks.
Overall, the decline in vasomotor symptom frequency remained on a persistent downward slope on both doses of fezolinetant for the full 52 weeks of the study, so that the reduction at 52 weeks was on the order of 25% greater than that seen at 12 weeks.
At 52 weeks, “you can see that individuals on placebo who were crossed over to an active treatment had a significant reduction in their hot flashes and look very much like those who were randomized to fezolinetant at the beginning of the study,” said Dr. Neal-Perry, who is chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.
Other outcomes also favored fezolinetant over placebo. For example, a reduction in sleep disturbance observed at 12 weeks was sustained over the full 52 weeks of the study. The reduction in sleep symptoms appeared to be slightly greater on the higher dose, but the benefit at 52 weeks among patients after the crossover was similar on either active arm.
No serious side effects identified
There were no serious drug-related treatment-emergent adverse events in any treatment group. One patient in the placebo arm (< 1%), two patients in the 30-mg fezolinetant arm (1.2%), and five patients in the 45-mg arm (3%) discontinued therapy for an adverse event considered to be treatment related.
“The most common side effect associated with fezolinetant was headache. There were no other side effects that led patients to pull out of the study,” Dr. Neal-Perry reported at the meeting, which was held in Atlanta and virtually.
According to Dr. Neal-Perry the vasomotor symptoms relative to menopause, which occur in almost all women, are moderate to severe in an estimated 35%-45%. Some groups, such as those with an elevated body mass index and African Americans, appear to be at even greater risk. Study enrollment was specifically designed to include these high-risk groups, but the subgroup efficacy data have not yet been analyzed.
Other drugs with a similar mechanism of action have not been brought forward because of concern about elevated liver enzymes, but Dr. Neal-Perry said that this does not appear to be an issue for fezolinetant, which was designed with greater specificity for the NK3 target than previous treatments.
If fezolinetant is approved, Dr. Neal-Perry expects this agent to fulfill an important unmet need because of the limitations of other nonhormonal solutions for control of menopause symptoms.
HT alternatives limited
For control of many menopause symptoms, particularly hot flashes, hormone therapy (HT) is the most efficacious, but Richard J. Santen, MD, emeritus professor and an endocrinologist at the University of Virginia, Charlottesville, agreed there is a need for alternatives.
In addition to those who have contraindications for HT, Dr. Santen said in an interview that this option is not acceptable to others “for a variety of reasons.” The problem is that the alternatives are limited.
“The SSRI agents and gabapentin are alternative nonhormonal agents, but they have side effects and are not as effective,” he said. Hot flashes “can be a major disruptor of quality of life,” so he is intrigued with the positive results achieved with fezolinetant.
“A new drug such as reported at the Endocrine Society meeting would be an important new addition to the armamentarium,” he said.
Dr. Neal-Perry reports no conflicts of interest.
A phase 3 trial has associated the neurokinin-3 (NK3)–receptor inhibitor fezolinetant, an oral therapy taken once daily, with substantial control over the symptoms of menopause, according to results of the randomized SKYLIGHT 2 trial.
The nonhormonal therapy has the potential to address an important unmet need, Genevieve Neal-Perry, MD, PhD, said at the annual meeting of the Endocrine Society.
The health risks of hormone therapy (HT) have “caused quite a few women to consider whether hormone replacement is right for them, and, in addition, there are other individuals who have hormone-responsive cancers or other disorders that might prohibit them [from using HT],” Dr. Neal-Perry said.
The NK3 receptor stimulates the thermoregulatory center in the hypothalamus. By blocking the NK3 receptor, vasodilation and other downstream effects are inhibited, explained Dr. Neal-Perry. She credited relatively recent advances in understanding the mechanisms of menopausal symptoms for identifying this and other potentially targetable mediators.
SKYLIGHT 2 trial: Two phases
In the double-blind multinational phase 3 SKYLIGHT 2 trial, 484 otherwise healthy symptomatic menopausal women were randomized to 30 mg of fezolinetant, 45 mg of fezolinetant, or placebo. The 120 participating centers were in North American and Europe.
In the first phase, safety and efficacy were evaluated over 12 weeks. In a second extension phase, placebo patients were rerandomized to one of the fezolinetant study doses. Those on active therapy remained in their assigned groups. All patients were then followed for an additional 40 weeks.
The coprimary endpoints were frequency and severity of moderate to severe vasomotor symptoms as reported by patients using an electronic diary. There were several secondary endpoints, including patient-reported outcomes regarding sleep quality.
As expected from other controlled trials, placebo patients achieved about a 40% reduction in moderate to severe vasomotor symptom frequency over the first 12 weeks. Relative to placebo, symptom frequency declined more quickly and steeply on fezolinetant. By week 12, both achieved reductions of about 60%. Statistical P values for the differences in the three arms were not provided, but Dr. Neal-Perry reported they were significant.
Vasomotor severity, like frequency, is reduced
The change in vasomotor severity, which subjects in the trial rated as better or worse, was also significant. The differences in the severity curves were less, but they separated in favor of the two active treatment arms by about 2 weeks, and the curves continued to show an advantage for fezolinetant over both the first 12 weeks and then the remaining 40 weeks.
Overall, the decline in vasomotor symptom frequency remained on a persistent downward slope on both doses of fezolinetant for the full 52 weeks of the study, so that the reduction at 52 weeks was on the order of 25% greater than that seen at 12 weeks.
At 52 weeks, “you can see that individuals on placebo who were crossed over to an active treatment had a significant reduction in their hot flashes and look very much like those who were randomized to fezolinetant at the beginning of the study,” said Dr. Neal-Perry, who is chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.
Other outcomes also favored fezolinetant over placebo. For example, a reduction in sleep disturbance observed at 12 weeks was sustained over the full 52 weeks of the study. The reduction in sleep symptoms appeared to be slightly greater on the higher dose, but the benefit at 52 weeks among patients after the crossover was similar on either active arm.
No serious side effects identified
There were no serious drug-related treatment-emergent adverse events in any treatment group. One patient in the placebo arm (< 1%), two patients in the 30-mg fezolinetant arm (1.2%), and five patients in the 45-mg arm (3%) discontinued therapy for an adverse event considered to be treatment related.
“The most common side effect associated with fezolinetant was headache. There were no other side effects that led patients to pull out of the study,” Dr. Neal-Perry reported at the meeting, which was held in Atlanta and virtually.
According to Dr. Neal-Perry the vasomotor symptoms relative to menopause, which occur in almost all women, are moderate to severe in an estimated 35%-45%. Some groups, such as those with an elevated body mass index and African Americans, appear to be at even greater risk. Study enrollment was specifically designed to include these high-risk groups, but the subgroup efficacy data have not yet been analyzed.
Other drugs with a similar mechanism of action have not been brought forward because of concern about elevated liver enzymes, but Dr. Neal-Perry said that this does not appear to be an issue for fezolinetant, which was designed with greater specificity for the NK3 target than previous treatments.
If fezolinetant is approved, Dr. Neal-Perry expects this agent to fulfill an important unmet need because of the limitations of other nonhormonal solutions for control of menopause symptoms.
HT alternatives limited
For control of many menopause symptoms, particularly hot flashes, hormone therapy (HT) is the most efficacious, but Richard J. Santen, MD, emeritus professor and an endocrinologist at the University of Virginia, Charlottesville, agreed there is a need for alternatives.
In addition to those who have contraindications for HT, Dr. Santen said in an interview that this option is not acceptable to others “for a variety of reasons.” The problem is that the alternatives are limited.
“The SSRI agents and gabapentin are alternative nonhormonal agents, but they have side effects and are not as effective,” he said. Hot flashes “can be a major disruptor of quality of life,” so he is intrigued with the positive results achieved with fezolinetant.
“A new drug such as reported at the Endocrine Society meeting would be an important new addition to the armamentarium,” he said.
Dr. Neal-Perry reports no conflicts of interest.
A phase 3 trial has associated the neurokinin-3 (NK3)–receptor inhibitor fezolinetant, an oral therapy taken once daily, with substantial control over the symptoms of menopause, according to results of the randomized SKYLIGHT 2 trial.
The nonhormonal therapy has the potential to address an important unmet need, Genevieve Neal-Perry, MD, PhD, said at the annual meeting of the Endocrine Society.
The health risks of hormone therapy (HT) have “caused quite a few women to consider whether hormone replacement is right for them, and, in addition, there are other individuals who have hormone-responsive cancers or other disorders that might prohibit them [from using HT],” Dr. Neal-Perry said.
The NK3 receptor stimulates the thermoregulatory center in the hypothalamus. By blocking the NK3 receptor, vasodilation and other downstream effects are inhibited, explained Dr. Neal-Perry. She credited relatively recent advances in understanding the mechanisms of menopausal symptoms for identifying this and other potentially targetable mediators.
SKYLIGHT 2 trial: Two phases
In the double-blind multinational phase 3 SKYLIGHT 2 trial, 484 otherwise healthy symptomatic menopausal women were randomized to 30 mg of fezolinetant, 45 mg of fezolinetant, or placebo. The 120 participating centers were in North American and Europe.
In the first phase, safety and efficacy were evaluated over 12 weeks. In a second extension phase, placebo patients were rerandomized to one of the fezolinetant study doses. Those on active therapy remained in their assigned groups. All patients were then followed for an additional 40 weeks.
The coprimary endpoints were frequency and severity of moderate to severe vasomotor symptoms as reported by patients using an electronic diary. There were several secondary endpoints, including patient-reported outcomes regarding sleep quality.
As expected from other controlled trials, placebo patients achieved about a 40% reduction in moderate to severe vasomotor symptom frequency over the first 12 weeks. Relative to placebo, symptom frequency declined more quickly and steeply on fezolinetant. By week 12, both achieved reductions of about 60%. Statistical P values for the differences in the three arms were not provided, but Dr. Neal-Perry reported they were significant.
Vasomotor severity, like frequency, is reduced
The change in vasomotor severity, which subjects in the trial rated as better or worse, was also significant. The differences in the severity curves were less, but they separated in favor of the two active treatment arms by about 2 weeks, and the curves continued to show an advantage for fezolinetant over both the first 12 weeks and then the remaining 40 weeks.
Overall, the decline in vasomotor symptom frequency remained on a persistent downward slope on both doses of fezolinetant for the full 52 weeks of the study, so that the reduction at 52 weeks was on the order of 25% greater than that seen at 12 weeks.
At 52 weeks, “you can see that individuals on placebo who were crossed over to an active treatment had a significant reduction in their hot flashes and look very much like those who were randomized to fezolinetant at the beginning of the study,” said Dr. Neal-Perry, who is chair of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill.
Other outcomes also favored fezolinetant over placebo. For example, a reduction in sleep disturbance observed at 12 weeks was sustained over the full 52 weeks of the study. The reduction in sleep symptoms appeared to be slightly greater on the higher dose, but the benefit at 52 weeks among patients after the crossover was similar on either active arm.
No serious side effects identified
There were no serious drug-related treatment-emergent adverse events in any treatment group. One patient in the placebo arm (< 1%), two patients in the 30-mg fezolinetant arm (1.2%), and five patients in the 45-mg arm (3%) discontinued therapy for an adverse event considered to be treatment related.
“The most common side effect associated with fezolinetant was headache. There were no other side effects that led patients to pull out of the study,” Dr. Neal-Perry reported at the meeting, which was held in Atlanta and virtually.
According to Dr. Neal-Perry the vasomotor symptoms relative to menopause, which occur in almost all women, are moderate to severe in an estimated 35%-45%. Some groups, such as those with an elevated body mass index and African Americans, appear to be at even greater risk. Study enrollment was specifically designed to include these high-risk groups, but the subgroup efficacy data have not yet been analyzed.
Other drugs with a similar mechanism of action have not been brought forward because of concern about elevated liver enzymes, but Dr. Neal-Perry said that this does not appear to be an issue for fezolinetant, which was designed with greater specificity for the NK3 target than previous treatments.
If fezolinetant is approved, Dr. Neal-Perry expects this agent to fulfill an important unmet need because of the limitations of other nonhormonal solutions for control of menopause symptoms.
HT alternatives limited
For control of many menopause symptoms, particularly hot flashes, hormone therapy (HT) is the most efficacious, but Richard J. Santen, MD, emeritus professor and an endocrinologist at the University of Virginia, Charlottesville, agreed there is a need for alternatives.
In addition to those who have contraindications for HT, Dr. Santen said in an interview that this option is not acceptable to others “for a variety of reasons.” The problem is that the alternatives are limited.
“The SSRI agents and gabapentin are alternative nonhormonal agents, but they have side effects and are not as effective,” he said. Hot flashes “can be a major disruptor of quality of life,” so he is intrigued with the positive results achieved with fezolinetant.
“A new drug such as reported at the Endocrine Society meeting would be an important new addition to the armamentarium,” he said.
Dr. Neal-Perry reports no conflicts of interest.
FROM ENDO 2022
About one in five U.S. pregnancies ended in abortion in 2020: Report
The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.
More than 930,000 abortions took place in the United States in 2020, up 8% from 862,000 abortions in 2017. About one in five pregnancies ended in abortion in 2020, the report said.
The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.
National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s.
The latest data show that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 and 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.
Similarly, the abortion ratio – or the number of abortions per 100 pregnancies – increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.
The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.
“Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion,” the institute wrote.
Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.
The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.
In some states – Illinois, Mississippi, and Oklahoma – there were substantial increases in the number of abortions, the institute said. In others – such as Missouri, Oregon, and North Dakota – there were substantially fewer abortions in 2020, compared with 2017.
The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.
New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions “nonessential” health care at the beginning of the pandemic.
In contrast, some numbers may have increased because of expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.
In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.
Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.
A version of this article first appeared on WebMD.com.
The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.
More than 930,000 abortions took place in the United States in 2020, up 8% from 862,000 abortions in 2017. About one in five pregnancies ended in abortion in 2020, the report said.
The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.
National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s.
The latest data show that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 and 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.
Similarly, the abortion ratio – or the number of abortions per 100 pregnancies – increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.
The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.
“Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion,” the institute wrote.
Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.
The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.
In some states – Illinois, Mississippi, and Oklahoma – there were substantial increases in the number of abortions, the institute said. In others – such as Missouri, Oregon, and North Dakota – there were substantially fewer abortions in 2020, compared with 2017.
The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.
New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions “nonessential” health care at the beginning of the pandemic.
In contrast, some numbers may have increased because of expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.
In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.
Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.
A version of this article first appeared on WebMD.com.
The number and rate of U.S. abortions increased between 2017 and 2020 after a 30-year decline, according to a new report from the Guttmacher Institute.
More than 930,000 abortions took place in the United States in 2020, up 8% from 862,000 abortions in 2017. About one in five pregnancies ended in abortion in 2020, the report said.
The Guttmacher Institute, a research organization that supports abortion rights, said the trend shows a rising need for abortion care as the Supreme Court is poised to overturn the Roe v. Wade decision in coming weeks.
National abortion numbers reached the lowest point in 2017 since the landmark 1973 ruling that legalized the procedure. In the years following the ruling, abortion numbers rose above 1.5 million annually throughout the 1980s and then began declining in the 1990s, though they remained above 1 million annually through the early 2010s.
The latest data show that the abortion rate increased from 13.5 abortions per 1,000 women between ages 15 and 44 in 2017 to 14.4 abortions per 1,000 women in 2020, marking a 7% increase.
Similarly, the abortion ratio – or the number of abortions per 100 pregnancies – increased from 18.4% in 2017 to 20.6% in 2020, marking a 12% increase.
The increase in abortions was accompanied by a 6% decline in births between 2017 and 2020, the Guttmacher Institute said.
“Because there were many more births (3.6 million) than abortions (930,000) in 2020, these patterns mean that fewer people were getting pregnant and, among those who did, a larger proportion chose to have an abortion,” the institute wrote.
Medication-related abortions accounted for 54% of U.S. abortions in 2020, according to the report, which was the first time they made up more than half of abortions.
The number of abortions increased in every region of the country between 2017 and 2020, the report shows. The increases were largest in the West (12%) and Midwest (10%), followed by 8% in the South and 2% in the Northeast.
In some states – Illinois, Mississippi, and Oklahoma – there were substantial increases in the number of abortions, the institute said. In others – such as Missouri, Oregon, and North Dakota – there were substantially fewer abortions in 2020, compared with 2017.
The COVID-19 pandemic may have led to a decline in some states. In New York, abortions increased 5% from 2017 to 2019 and then fell 6% between 2019 and 2020. About 10% of clinics in New York paused or stopped abortion care in 2020 when the pandemic started.
New laws likely affected the numbers as well. Texas had a 7% increase between 2017 and 2019, followed by a 2% decrease between 2019 and 2020, which overlapped with restrictions that deemed abortions “nonessential” health care at the beginning of the pandemic.
In contrast, some numbers may have increased because of expanded Medicaid funding. Illinois began allowing state Medicaid funds to pay for abortions in January 2018, and abortions increased 25% between 2017 and 2020.
In Missouri, abortions decreased substantially from 4,710 in 2017 to 170 in 2020, the report shows, but the number of Missouri residents who traveled to Illinois for abortions increased to more than 6,500.
Every 3 years, the Guttmacher Institute contacts U.S. facilities that provide abortions to collect information about services, including the total number of abortions. The most recent count was completed in May, representing 1,687 health care facilities that provided abortions in 2019 or 2020. A full summary of the data will be published later this year in a peer-reviewed journal article.
A version of this article first appeared on WebMD.com.
For cancer prevention, not all plant-based diets are equal
researchers have found.
The study of more than 65,000 people showed that plant-based diets that were high in whole grains, fruits, and vegetables appear to be more protective against breast cancer than diets rich in processed plant-based products, such as juice and chips.
“Results suggest that the best plant-based diet for breast cancer prevention could be a healthy plant-based diet comprising fruit, vegetables, whole grains, nuts, and legumes,” said Sanam Shah, MBBS, FCPS, MPH, a doctoral candidate in epidemiology at Paris-Saclay University, who is the lead author of the new study. “In contrast, an unhealthy plant-based diet comprising higher intakes of primarily processed products of plant origin, such as refined grains, fruit juices, sweets, desserts, and potatoes, would be worse for breast cancer prevention.”
Dr. Shah’s group is presenting their research online at the annual meeting of the American Society for Nutrition.
Although the role of plant-based diets in cancer prevention has received extensive attention, Dr. Shah said few studies have assessed the influence of the quality of those diets on the risk of breast cancer.
Dr. Shah and colleagues conducted a prospective cohort study to investigate the link between healthy and unhealthy plant-based diets and breast cancer risk. Unlike other studies, the researchers also evaluated the effect of a gradual decrease in animal products in diets on health.
Dr. Shah’s group followed 65,574 postmenopausal women in France (mean age, 52.8 years) from 1993 to 2014. The researchers used self-reported food questionnaires to classify women into groups on the basis of adherence to a mostly plant or animal diet. Plant-based diets did not exclude meat but had more plant than animal products, Dr. Shah said. The researchers also grouped women on the basis of how healthy the plant-based diets were.
Over the 21-year study period, 3,968 women were diagnosed with breast cancer. Those who adhered to a more healthful plant-based diet had a 14% lower risk than average of developing breast cancer, while those who adhered to a less healthful plant-based diet had a 20% greater risk of developing the disease.
Nutritional quality varies greatly across plant-based foods. Quality plant-based diets should focus on variety to avoid nutritional deficiencies in iron, zinc, calcium, and vitamin B12, Dr. Shah said.
“The study by Shah and coworkers underscores the importance of considering more global aspects of the diet rather than single components when examining relationships between diet and health,” said Megan McCrory, PhD, research associate professor of nutrition at Boston University. “As the study illustrates, plant-based diets as a whole are not always healthy and may also contain less desirable nutrients and foods.”
Abstracts in the conference have been selected by a board of experts for presentation but have not yet been peer reviewed. All findings are to be regarded as preliminary until they are published in peer-reviewed articles. Dr. Shah and Dr. McCrory disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers have found.
The study of more than 65,000 people showed that plant-based diets that were high in whole grains, fruits, and vegetables appear to be more protective against breast cancer than diets rich in processed plant-based products, such as juice and chips.
“Results suggest that the best plant-based diet for breast cancer prevention could be a healthy plant-based diet comprising fruit, vegetables, whole grains, nuts, and legumes,” said Sanam Shah, MBBS, FCPS, MPH, a doctoral candidate in epidemiology at Paris-Saclay University, who is the lead author of the new study. “In contrast, an unhealthy plant-based diet comprising higher intakes of primarily processed products of plant origin, such as refined grains, fruit juices, sweets, desserts, and potatoes, would be worse for breast cancer prevention.”
Dr. Shah’s group is presenting their research online at the annual meeting of the American Society for Nutrition.
Although the role of plant-based diets in cancer prevention has received extensive attention, Dr. Shah said few studies have assessed the influence of the quality of those diets on the risk of breast cancer.
Dr. Shah and colleagues conducted a prospective cohort study to investigate the link between healthy and unhealthy plant-based diets and breast cancer risk. Unlike other studies, the researchers also evaluated the effect of a gradual decrease in animal products in diets on health.
Dr. Shah’s group followed 65,574 postmenopausal women in France (mean age, 52.8 years) from 1993 to 2014. The researchers used self-reported food questionnaires to classify women into groups on the basis of adherence to a mostly plant or animal diet. Plant-based diets did not exclude meat but had more plant than animal products, Dr. Shah said. The researchers also grouped women on the basis of how healthy the plant-based diets were.
Over the 21-year study period, 3,968 women were diagnosed with breast cancer. Those who adhered to a more healthful plant-based diet had a 14% lower risk than average of developing breast cancer, while those who adhered to a less healthful plant-based diet had a 20% greater risk of developing the disease.
Nutritional quality varies greatly across plant-based foods. Quality plant-based diets should focus on variety to avoid nutritional deficiencies in iron, zinc, calcium, and vitamin B12, Dr. Shah said.
“The study by Shah and coworkers underscores the importance of considering more global aspects of the diet rather than single components when examining relationships between diet and health,” said Megan McCrory, PhD, research associate professor of nutrition at Boston University. “As the study illustrates, plant-based diets as a whole are not always healthy and may also contain less desirable nutrients and foods.”
Abstracts in the conference have been selected by a board of experts for presentation but have not yet been peer reviewed. All findings are to be regarded as preliminary until they are published in peer-reviewed articles. Dr. Shah and Dr. McCrory disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
researchers have found.
The study of more than 65,000 people showed that plant-based diets that were high in whole grains, fruits, and vegetables appear to be more protective against breast cancer than diets rich in processed plant-based products, such as juice and chips.
“Results suggest that the best plant-based diet for breast cancer prevention could be a healthy plant-based diet comprising fruit, vegetables, whole grains, nuts, and legumes,” said Sanam Shah, MBBS, FCPS, MPH, a doctoral candidate in epidemiology at Paris-Saclay University, who is the lead author of the new study. “In contrast, an unhealthy plant-based diet comprising higher intakes of primarily processed products of plant origin, such as refined grains, fruit juices, sweets, desserts, and potatoes, would be worse for breast cancer prevention.”
Dr. Shah’s group is presenting their research online at the annual meeting of the American Society for Nutrition.
Although the role of plant-based diets in cancer prevention has received extensive attention, Dr. Shah said few studies have assessed the influence of the quality of those diets on the risk of breast cancer.
Dr. Shah and colleagues conducted a prospective cohort study to investigate the link between healthy and unhealthy plant-based diets and breast cancer risk. Unlike other studies, the researchers also evaluated the effect of a gradual decrease in animal products in diets on health.
Dr. Shah’s group followed 65,574 postmenopausal women in France (mean age, 52.8 years) from 1993 to 2014. The researchers used self-reported food questionnaires to classify women into groups on the basis of adherence to a mostly plant or animal diet. Plant-based diets did not exclude meat but had more plant than animal products, Dr. Shah said. The researchers also grouped women on the basis of how healthy the plant-based diets were.
Over the 21-year study period, 3,968 women were diagnosed with breast cancer. Those who adhered to a more healthful plant-based diet had a 14% lower risk than average of developing breast cancer, while those who adhered to a less healthful plant-based diet had a 20% greater risk of developing the disease.
Nutritional quality varies greatly across plant-based foods. Quality plant-based diets should focus on variety to avoid nutritional deficiencies in iron, zinc, calcium, and vitamin B12, Dr. Shah said.
“The study by Shah and coworkers underscores the importance of considering more global aspects of the diet rather than single components when examining relationships between diet and health,” said Megan McCrory, PhD, research associate professor of nutrition at Boston University. “As the study illustrates, plant-based diets as a whole are not always healthy and may also contain less desirable nutrients and foods.”
Abstracts in the conference have been selected by a board of experts for presentation but have not yet been peer reviewed. All findings are to be regarded as preliminary until they are published in peer-reviewed articles. Dr. Shah and Dr. McCrory disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NUTRITION 2022
Can too much sleep raise the risk of cancer?
The findings reveal that sleeping 10-plus hours may increase a woman’s risk of getting cancer and both men and women’s risk of dying from cancer.
The researchers say their findings may help refine sleep recommendations in Japan, which currently advise working, middle-aged adults to sleep “as long as they can.”
Based on the new findings, a sleep duration of 6-8 hours for men and 6-9 hours for women “may be the safest” regarding cancer incidence and mortality risk among Japanese adults, the authors conclude.
The findings were published online in the International Journal of Cancer.
The literature on sleep time and cancer risk is mixed. A trio of meta-analyses conducted between 2016 and 2019 found that long sleep duration, but not short, was associated with a slightly elevated risk of all cancer mortality in Asians.
A separate meta-analysis conducted in 2018 found that both short and long sleep durations were not related to cancer incidence. But in the stratified analysis, shorter sleep time was associated with 36% increased cancer risk among Asians.
To investigate further, the researchers pooled data from six population-based cohorts that included 271,694 adults – 126,930 men and 144,764 women – with 40,751 total incident cancer cases and 18,323 total cancer deaths during a follow-up lasting about 5.9 million person-years.
In the multivariable analysis, longer sleep duration was not associated with total cancer incidence in men. In women, however, sleeping 10 or more hours vs. 7 was associated with a 19% increased risk of cancer.
In addition, sleeping 10 or more hours was associated with an increased risk of dying from cancer in women (hazard ratio, 1.44) and men (HR, 1.18).
Sleeping for 5 hours or fewer, compared with 7, was not associated with cancer incidence and mortality. However, among postmenopausal women, shorter sleep durations did increase the risk of dying from cancer (HR, 1.15).
The authors highlight several strengths of the analysis, including a large sample size as well as stratification of the results by body mass index and menopause status, which has rarely been done in previous studies.
Limitations include self-reported sleep durations and lack of data on sleep quality. The researchers note that the mechanism by which sleep time may influence cancer incidence and mortality is unclear but likely to be complex and cancer site specific.
It’s also possible that reverse causation could explain associations between sleep duration and cancer occurrence and mortality – with pain from cancer, for instance, impairing sleep duration and quality. However, the sensitivity analysis found no evidence of reverse causality or other confounding factors.
Based on these findings, the researchers say sleep duration “may be an important variable to include in cancer incidence and mortality risk prediction models.”
The study had no specific funding. The authors declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The findings reveal that sleeping 10-plus hours may increase a woman’s risk of getting cancer and both men and women’s risk of dying from cancer.
The researchers say their findings may help refine sleep recommendations in Japan, which currently advise working, middle-aged adults to sleep “as long as they can.”
Based on the new findings, a sleep duration of 6-8 hours for men and 6-9 hours for women “may be the safest” regarding cancer incidence and mortality risk among Japanese adults, the authors conclude.
The findings were published online in the International Journal of Cancer.
The literature on sleep time and cancer risk is mixed. A trio of meta-analyses conducted between 2016 and 2019 found that long sleep duration, but not short, was associated with a slightly elevated risk of all cancer mortality in Asians.
A separate meta-analysis conducted in 2018 found that both short and long sleep durations were not related to cancer incidence. But in the stratified analysis, shorter sleep time was associated with 36% increased cancer risk among Asians.
To investigate further, the researchers pooled data from six population-based cohorts that included 271,694 adults – 126,930 men and 144,764 women – with 40,751 total incident cancer cases and 18,323 total cancer deaths during a follow-up lasting about 5.9 million person-years.
In the multivariable analysis, longer sleep duration was not associated with total cancer incidence in men. In women, however, sleeping 10 or more hours vs. 7 was associated with a 19% increased risk of cancer.
In addition, sleeping 10 or more hours was associated with an increased risk of dying from cancer in women (hazard ratio, 1.44) and men (HR, 1.18).
Sleeping for 5 hours or fewer, compared with 7, was not associated with cancer incidence and mortality. However, among postmenopausal women, shorter sleep durations did increase the risk of dying from cancer (HR, 1.15).
The authors highlight several strengths of the analysis, including a large sample size as well as stratification of the results by body mass index and menopause status, which has rarely been done in previous studies.
Limitations include self-reported sleep durations and lack of data on sleep quality. The researchers note that the mechanism by which sleep time may influence cancer incidence and mortality is unclear but likely to be complex and cancer site specific.
It’s also possible that reverse causation could explain associations between sleep duration and cancer occurrence and mortality – with pain from cancer, for instance, impairing sleep duration and quality. However, the sensitivity analysis found no evidence of reverse causality or other confounding factors.
Based on these findings, the researchers say sleep duration “may be an important variable to include in cancer incidence and mortality risk prediction models.”
The study had no specific funding. The authors declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The findings reveal that sleeping 10-plus hours may increase a woman’s risk of getting cancer and both men and women’s risk of dying from cancer.
The researchers say their findings may help refine sleep recommendations in Japan, which currently advise working, middle-aged adults to sleep “as long as they can.”
Based on the new findings, a sleep duration of 6-8 hours for men and 6-9 hours for women “may be the safest” regarding cancer incidence and mortality risk among Japanese adults, the authors conclude.
The findings were published online in the International Journal of Cancer.
The literature on sleep time and cancer risk is mixed. A trio of meta-analyses conducted between 2016 and 2019 found that long sleep duration, but not short, was associated with a slightly elevated risk of all cancer mortality in Asians.
A separate meta-analysis conducted in 2018 found that both short and long sleep durations were not related to cancer incidence. But in the stratified analysis, shorter sleep time was associated with 36% increased cancer risk among Asians.
To investigate further, the researchers pooled data from six population-based cohorts that included 271,694 adults – 126,930 men and 144,764 women – with 40,751 total incident cancer cases and 18,323 total cancer deaths during a follow-up lasting about 5.9 million person-years.
In the multivariable analysis, longer sleep duration was not associated with total cancer incidence in men. In women, however, sleeping 10 or more hours vs. 7 was associated with a 19% increased risk of cancer.
In addition, sleeping 10 or more hours was associated with an increased risk of dying from cancer in women (hazard ratio, 1.44) and men (HR, 1.18).
Sleeping for 5 hours or fewer, compared with 7, was not associated with cancer incidence and mortality. However, among postmenopausal women, shorter sleep durations did increase the risk of dying from cancer (HR, 1.15).
The authors highlight several strengths of the analysis, including a large sample size as well as stratification of the results by body mass index and menopause status, which has rarely been done in previous studies.
Limitations include self-reported sleep durations and lack of data on sleep quality. The researchers note that the mechanism by which sleep time may influence cancer incidence and mortality is unclear but likely to be complex and cancer site specific.
It’s also possible that reverse causation could explain associations between sleep duration and cancer occurrence and mortality – with pain from cancer, for instance, impairing sleep duration and quality. However, the sensitivity analysis found no evidence of reverse causality or other confounding factors.
Based on these findings, the researchers say sleep duration “may be an important variable to include in cancer incidence and mortality risk prediction models.”
The study had no specific funding. The authors declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF CANCER
‘Forever chemicals’ linked to hypertension in middle-aged women
In a large, prospective study, researchers found an association between higher blood levels of PFAS and increased risk of hypertension in middle-aged women. Women in the highest tertile of overall PFAS concentrations had a 71% increased risk of developing hypertension.
“Our findings suggest that long-term cumulative exposure, even before midlife, may increase the risk of high blood pressure, and therefore, the benefit of reducing the population exposure to PFAS and potential prevention of high blood pressure and other health conditions would be enormous,” Sung Kyun Park, ScD, MPH, University of Michigan School of Public Health, Ann Arbor, said in an interview.
The study was published online in Hypertension.
Everywhere and forever
“PFAS are forever chemicals as well as everywhere chemicals,” Dr. Park noted.
Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and drinking water. They have been detected in the blood of most people and have been linked to a variety of health concerns.
“A few studies showed an association between PFAS and hypertension, but those were cross-sectional and examined prevalence of hypertension. It was unclear whether PFAS are associated with the development (incidence) of hypertension,” Dr. Park explained.
For their study, the researchers examined the association between serum concentrations of PFAS and risks of incident hypertension in 1,058 initially normotensive women participating in the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS). They were followed annually between 1999 and 2017.
During 11,722 person-years of follow-up, 470 of the women developed hypertension, at a rate of 40.1 cases per 1,000 person-years. Hypertension was defined as blood pressure of at least 140 mm Hg systolic or at least 90 mm Hg diastolic or receiving antihypertensive treatment.
Women in the highest tertile of baseline serum concentration of perfluorooctane sulfonate (PFOS) had a 42% higher risk of developing hypertension, compared with peers in the lowest tertile (adjusted hazard ratio, 1.42; 95% confidence interval, 1.19-1.68; P trend = .01).
Similar results were found for perfluorooctanoate (PFOA) and 2-N-ethyl-perfluorooctane sulfonamido acetate (EtFOSAA), with 47% (aHR, 1.47; 95% CI, 1.24-1.75; P trend = .01) and 42% (aHR, 1.42; 95% CI, 1.19-1.70; P trend = .01) higher risks of incident hypertension, comparing the highest to the lowest tertiles.
The risks persisted after adjusting for various factors, including race, study site, education, financial strain, smoking status, alcohol use, total calorie intake, and menopausal status.
In the PFAS “mixture” analysis, women in the highest tertile of overall PFAS concentrations were 71% more likely to develop hypertension during follow-up, compared with women in the lowest tertile (aHR, 1.71; 95% CI, 1.15-2.54; P trend = .008).
“These findings suggest that PFAS might be an underappreciated contributing factor to women’s cardiovascular disease risk,” the researchers write.
They caution that the study only included middle-aged women and that it is unclear whether the findings hold for middle-aged men.
“This is an important question, but the answer is that we do not know,” Dr. Park told this news organization.
“Women become more susceptible to metabolic changes and hypertension risk during the menopausal transition. Our findings suggest that PFAS may play a role in the development of hypertension in women during this critical life stage,” Dr. Park said.
The researchers say more research is needed to confirm and expand the findings and to find ways to reduce PFAS exposure.
“If confirmed in future studies, these findings suggest that understanding human exposure to PFAS and developing effective strategies to reduce PFAS exposure may help prevent the development of hypertension and thereby reduce the global burden of CVD,” the researchers write.
‘The more we learn, the worse it gets’
This is an “interesting” study and shows that “the more we learn about PFAS, the worse it seems to get,” Ankur Shah, MD, division of kidney disease and hypertension, Warren Alpert Medical School of Brown University, Providence, R.I., said in an interview.
“This multisite, multiracial and multiethnic, community-based longitudinal study establishes an association between PFAS and hypertension,” said Dr. Shah, who wasn’t involved in the study.
“This adds to a growing literature base of associations of PFAS with illnesses, including malignancy, thyroid disorders, diabetes, ulcerative colitis, hyperlipidemia, and pregnancy-induced hypertension,” he noted.
Dr. Shah also noted that the authors adjusted for race and ethnicity, study site, education, financial strain, smoking status, environmental tobacco smoke, alcohol consumption, total calorie intake, and menopausal status “and still found a strong association.”
“Still to be determined are both whether PFAS are the causative agent or if there is an unmeasured/unadjusted for entity which has resulted in both increased PFAS exposure and hypertension, as well as if PFAS are causative, if reduction in PFAS exposure would be result in blood pressure reduction,” Dr. Shah added.
The study had no sources of funding. Dr. Park and Dr. Shah have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a large, prospective study, researchers found an association between higher blood levels of PFAS and increased risk of hypertension in middle-aged women. Women in the highest tertile of overall PFAS concentrations had a 71% increased risk of developing hypertension.
“Our findings suggest that long-term cumulative exposure, even before midlife, may increase the risk of high blood pressure, and therefore, the benefit of reducing the population exposure to PFAS and potential prevention of high blood pressure and other health conditions would be enormous,” Sung Kyun Park, ScD, MPH, University of Michigan School of Public Health, Ann Arbor, said in an interview.
The study was published online in Hypertension.
Everywhere and forever
“PFAS are forever chemicals as well as everywhere chemicals,” Dr. Park noted.
Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and drinking water. They have been detected in the blood of most people and have been linked to a variety of health concerns.
“A few studies showed an association between PFAS and hypertension, but those were cross-sectional and examined prevalence of hypertension. It was unclear whether PFAS are associated with the development (incidence) of hypertension,” Dr. Park explained.
For their study, the researchers examined the association between serum concentrations of PFAS and risks of incident hypertension in 1,058 initially normotensive women participating in the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS). They were followed annually between 1999 and 2017.
During 11,722 person-years of follow-up, 470 of the women developed hypertension, at a rate of 40.1 cases per 1,000 person-years. Hypertension was defined as blood pressure of at least 140 mm Hg systolic or at least 90 mm Hg diastolic or receiving antihypertensive treatment.
Women in the highest tertile of baseline serum concentration of perfluorooctane sulfonate (PFOS) had a 42% higher risk of developing hypertension, compared with peers in the lowest tertile (adjusted hazard ratio, 1.42; 95% confidence interval, 1.19-1.68; P trend = .01).
Similar results were found for perfluorooctanoate (PFOA) and 2-N-ethyl-perfluorooctane sulfonamido acetate (EtFOSAA), with 47% (aHR, 1.47; 95% CI, 1.24-1.75; P trend = .01) and 42% (aHR, 1.42; 95% CI, 1.19-1.70; P trend = .01) higher risks of incident hypertension, comparing the highest to the lowest tertiles.
The risks persisted after adjusting for various factors, including race, study site, education, financial strain, smoking status, alcohol use, total calorie intake, and menopausal status.
In the PFAS “mixture” analysis, women in the highest tertile of overall PFAS concentrations were 71% more likely to develop hypertension during follow-up, compared with women in the lowest tertile (aHR, 1.71; 95% CI, 1.15-2.54; P trend = .008).
“These findings suggest that PFAS might be an underappreciated contributing factor to women’s cardiovascular disease risk,” the researchers write.
They caution that the study only included middle-aged women and that it is unclear whether the findings hold for middle-aged men.
“This is an important question, but the answer is that we do not know,” Dr. Park told this news organization.
“Women become more susceptible to metabolic changes and hypertension risk during the menopausal transition. Our findings suggest that PFAS may play a role in the development of hypertension in women during this critical life stage,” Dr. Park said.
The researchers say more research is needed to confirm and expand the findings and to find ways to reduce PFAS exposure.
“If confirmed in future studies, these findings suggest that understanding human exposure to PFAS and developing effective strategies to reduce PFAS exposure may help prevent the development of hypertension and thereby reduce the global burden of CVD,” the researchers write.
‘The more we learn, the worse it gets’
This is an “interesting” study and shows that “the more we learn about PFAS, the worse it seems to get,” Ankur Shah, MD, division of kidney disease and hypertension, Warren Alpert Medical School of Brown University, Providence, R.I., said in an interview.
“This multisite, multiracial and multiethnic, community-based longitudinal study establishes an association between PFAS and hypertension,” said Dr. Shah, who wasn’t involved in the study.
“This adds to a growing literature base of associations of PFAS with illnesses, including malignancy, thyroid disorders, diabetes, ulcerative colitis, hyperlipidemia, and pregnancy-induced hypertension,” he noted.
Dr. Shah also noted that the authors adjusted for race and ethnicity, study site, education, financial strain, smoking status, environmental tobacco smoke, alcohol consumption, total calorie intake, and menopausal status “and still found a strong association.”
“Still to be determined are both whether PFAS are the causative agent or if there is an unmeasured/unadjusted for entity which has resulted in both increased PFAS exposure and hypertension, as well as if PFAS are causative, if reduction in PFAS exposure would be result in blood pressure reduction,” Dr. Shah added.
The study had no sources of funding. Dr. Park and Dr. Shah have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a large, prospective study, researchers found an association between higher blood levels of PFAS and increased risk of hypertension in middle-aged women. Women in the highest tertile of overall PFAS concentrations had a 71% increased risk of developing hypertension.
“Our findings suggest that long-term cumulative exposure, even before midlife, may increase the risk of high blood pressure, and therefore, the benefit of reducing the population exposure to PFAS and potential prevention of high blood pressure and other health conditions would be enormous,” Sung Kyun Park, ScD, MPH, University of Michigan School of Public Health, Ann Arbor, said in an interview.
The study was published online in Hypertension.
Everywhere and forever
“PFAS are forever chemicals as well as everywhere chemicals,” Dr. Park noted.
Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and drinking water. They have been detected in the blood of most people and have been linked to a variety of health concerns.
“A few studies showed an association between PFAS and hypertension, but those were cross-sectional and examined prevalence of hypertension. It was unclear whether PFAS are associated with the development (incidence) of hypertension,” Dr. Park explained.
For their study, the researchers examined the association between serum concentrations of PFAS and risks of incident hypertension in 1,058 initially normotensive women participating in the Study of Women’s Health Across the Nation-Multi-Pollutant Study (SWAN-MPS). They were followed annually between 1999 and 2017.
During 11,722 person-years of follow-up, 470 of the women developed hypertension, at a rate of 40.1 cases per 1,000 person-years. Hypertension was defined as blood pressure of at least 140 mm Hg systolic or at least 90 mm Hg diastolic or receiving antihypertensive treatment.
Women in the highest tertile of baseline serum concentration of perfluorooctane sulfonate (PFOS) had a 42% higher risk of developing hypertension, compared with peers in the lowest tertile (adjusted hazard ratio, 1.42; 95% confidence interval, 1.19-1.68; P trend = .01).
Similar results were found for perfluorooctanoate (PFOA) and 2-N-ethyl-perfluorooctane sulfonamido acetate (EtFOSAA), with 47% (aHR, 1.47; 95% CI, 1.24-1.75; P trend = .01) and 42% (aHR, 1.42; 95% CI, 1.19-1.70; P trend = .01) higher risks of incident hypertension, comparing the highest to the lowest tertiles.
The risks persisted after adjusting for various factors, including race, study site, education, financial strain, smoking status, alcohol use, total calorie intake, and menopausal status.
In the PFAS “mixture” analysis, women in the highest tertile of overall PFAS concentrations were 71% more likely to develop hypertension during follow-up, compared with women in the lowest tertile (aHR, 1.71; 95% CI, 1.15-2.54; P trend = .008).
“These findings suggest that PFAS might be an underappreciated contributing factor to women’s cardiovascular disease risk,” the researchers write.
They caution that the study only included middle-aged women and that it is unclear whether the findings hold for middle-aged men.
“This is an important question, but the answer is that we do not know,” Dr. Park told this news organization.
“Women become more susceptible to metabolic changes and hypertension risk during the menopausal transition. Our findings suggest that PFAS may play a role in the development of hypertension in women during this critical life stage,” Dr. Park said.
The researchers say more research is needed to confirm and expand the findings and to find ways to reduce PFAS exposure.
“If confirmed in future studies, these findings suggest that understanding human exposure to PFAS and developing effective strategies to reduce PFAS exposure may help prevent the development of hypertension and thereby reduce the global burden of CVD,” the researchers write.
‘The more we learn, the worse it gets’
This is an “interesting” study and shows that “the more we learn about PFAS, the worse it seems to get,” Ankur Shah, MD, division of kidney disease and hypertension, Warren Alpert Medical School of Brown University, Providence, R.I., said in an interview.
“This multisite, multiracial and multiethnic, community-based longitudinal study establishes an association between PFAS and hypertension,” said Dr. Shah, who wasn’t involved in the study.
“This adds to a growing literature base of associations of PFAS with illnesses, including malignancy, thyroid disorders, diabetes, ulcerative colitis, hyperlipidemia, and pregnancy-induced hypertension,” he noted.
Dr. Shah also noted that the authors adjusted for race and ethnicity, study site, education, financial strain, smoking status, environmental tobacco smoke, alcohol consumption, total calorie intake, and menopausal status “and still found a strong association.”
“Still to be determined are both whether PFAS are the causative agent or if there is an unmeasured/unadjusted for entity which has resulted in both increased PFAS exposure and hypertension, as well as if PFAS are causative, if reduction in PFAS exposure would be result in blood pressure reduction,” Dr. Shah added.
The study had no sources of funding. Dr. Park and Dr. Shah have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION
Interventional Radiology Treatment for Uterine Fibroids
Interventional approaches are being used as a standard of care more and more to provide image-guided techniques to perform minimally invasive procedures. With this being said, what are some indications and best practices used with interventional radiology for the treatment of uterine fibroids?
Dr. Boone: Interventional radiologists offer minimally invasive non-surgical treatment options for the management of symptomatic uterine fibroids. These approaches include uterine artery embolization or UAE. It may also be called uterine fibroid embolization or UFE. In this procedure, the uterine arteries are embolized with permanent embolic particles to block blood flow to the fibroids.
The goal of this treatment is to shrink the fibroids. It usually leads to a gradual shrinkage of fibroids and can also be particularly effective for reducing bleeding from fibroids. This procedure has been around for more than 20 years and has a lot of data describing its safety and efficacy.
Another treatment, which is non-invasive, but some interventional radiologists offer, is magnetic resonance-guided focused ultrasound. This might also be called high intensity focused ultrasound or HIFU. In this treatment, MRI is used to direct high intensity ultrasound waves onto the fibroid. This focused application of these high intensity ultrasound waves generates heat and leads to coagulative necrosis of the fibroid.
This procedure is newer than uterine artery embolization, but it has some benefits of avoiding ionizing radiation. Although, it can have longer procedure times. For both procedures, the indications are symptomatic uterine fibroids.
The symptoms we're concerned about include menorrhagia, which can result in anemia. There are also “bulk” symptoms, related to the actual bulk of the fibroids, which can cause bladder or bowel dysfunction. Some patients also have protrusion of their abdomen, dysmenorrhea, and infertility.
The goal is to help reduce those symptoms. The Society for Interventional Radiology has published best practices. For expected outcomes, with the uterine artery embolization, it is 50% to 60% reduction in the size of fibroid of the fibroids themselves, 40% to 50% reduction in the size of the uterus, 88% to 92% of reduction of the bulk symptoms.
Every consultation should discuss the range of treatment options—the medical, surgical, and non-surgical or interventional. I wanted to point out that there is a real need for this. The Society for Interventional Radiology commissioned a poll in 2017 of patients–women who had been diagnosed with uterine fibroids—and found that 44% of patients noted never hearing of uterine artery embolization. Eleven percent of these patients believed that hysterectomy was their only treatment option. Further, a recent article from NPR noted concerns about disparities in which women of color, particularly Black women, were not offered or made aware of more minimally invasive options during consultations. Very broad patient education about the range of treatment options is important.
In addition, we want to consider other differential diagnoses that patients may have, such as adenomyosis or rare malignancies. Leiomyosarcoma can present with similar symptoms to uterine fibroids or can even coexist with uterine fibroids. In the case of leiomyosarcoma, the treatment pathway may be completely different, and we don't want to undertreat or delay diagnosis. Other considerations that can have bearing on the selection of treatment can be the number and the size of the fibroids.
To help with the decision-making process, these patients need a complete workup. We want to get lab tests. We want to also make sure they have a complete gynecologic evaluation, which includes an ultrasound and an MRI. Particularly, contrast-enhanced MRI has great accuracy for evaluating fibroid location because we’re imaging the entire pelvis. We can see where everything is and map out our target fibroids.
We can also see the enhancement characteristics of the fibroids. Some fibroids are not just supplied by uterine arteries but ovarian arteries, which can affect the efficacy of the treatment and even some of the risks of the treatment.
What is your role and particularly what is the role of the Nurse Practitioner when thinking about diagnosis and treatment and how do you and the nurse practitioner work together?
Dr. Boone: I would say the specific roles for the physicians and nurse practitioners on an interventional radiology team can vary with a lot of different factors. It could depend on the practice setting, such as, whether you're in a busy academic center or in a small private practice. It can depend on the types of cases we're doing. Even some of the local regulations of the institution and state can come into play. The roles tend to be laid out and specified by the supervising physician based on this context.
For example, ideally, all of that work up and planning is happening in that clinic setting before the patient even comes down to the suite for the procedure. In this setting, nurse practitioners can provide a significant role in obtaining the data that we need. They'll perform the history and physical exam, which helps the team learn about the patients. It helps answer relevant questions: What symptoms is the patient having? What are their wishes for the procedure? What are the things they're hoping to avoid or hoping to get from having the procedure done? They review for those relevant labs and imaging, and in order to recognize the information we don’t have.
The next step is developing the assessment and plan which is usually done in conjunction with the interventional radiologist. This is especially important with new patients. Once that assessment and plan are determined, the nurse practitioner can be helpful in explaining the process in depth to the patient and their family or caregivers while they're in the clinic.
Another important role for nurse practitioners in this setting is the consent. I can talk a little bit more about that later, but informed consent is critical. It can be a pretty extensive discussion, especially if we want to talk about this wide range of treatment options. So that is substantial value added by the nurse practitioner.
The other important role is the follow up visits, which may be almost completely independently by a nurse practitioner. They see patients post-procedure, evaluating how they’re doing and what's changed. This is critical because we need to determine: 1. Have we gotten the result that we want? 2. Do we want to give more time to see changes? and; 3. Do we need to do another procedure? We also want to follow these patients and their response to treatment to look out for something concerning that might raise concern for malignancy, such as the fibroid continuing to grow rapidly. Those follow up visits are also a critical role for NPs.
In the inpatient setting, the attending and senior interventional radiology residents may actually determine the roles and tasks the other team members are going to perform to help the IR service run smoothly. And typically, nurse practitioners and also physician assistants will share many of those responsibilities of running that interventional radiology service outside of the procedure room.
There are also cases where nurse practitioners and physician assistants can have a dedicated role in performing certain procedures. Personally, I've seen physician assistants in these cases, where they were our dedicated bone marrow biopsy providers. Throughout the day, they would do all the bone marrow biopsy cases. Another example I saw was placement of vascular access catheters, whether for ports or dialysis. NPs see many patients throughout the day and perform these procedures. This is helpful because these are very popular procedures and are needed. While those are being done, it frees up time for the other members of the team to do other, more time-consuming, procedures as well.
In all cases, we work closely together. We're sharing this responsibility of patient care. We communicate frequently and it's a valuable team dynamic. NPs are fantastic team members
Dr. Boone, you talked about the treatments and how you work together with NPs. Can you touch on the interventional procedures and the value or benefit over conservative treatments and drugs, particularly, where you receive support or recommendations from nurse practitioners at this stage?
Dr. Boone: Regarding more conservative treatment, there’s expectant management where the patients may not want to undergo an intervention at that time. You’re following the patient and watching for possible worsening of symptoms that may lead to a change in management.
There’s also medical management, which generally gets broken down into hormonal or non-hormonal medications. Among these, there's a lot of different drugs that are available. Among the more frequently used hormonal therapies would be gonadotropin-releasing hormone agonists.
The non-hormonal therapies such as, NSAIDs, or procoagulation medications, like tranexamic acid, are more targeted at symptom control. Particularly, these target the abnormal uterine bleeding and the pain.
For these therapies, the limitations can be side-effect profiles. Sometimes these side effects are just not acceptable to patients. Hormonal therapies like the gonadotropin-releasing hormone agonists create this hypoestrogenic state. Patients may not like having the menopause-like symptoms.
Additionally, medications are more short-term in their benefit. For example, with the cessation of gonadotropin-releasing hormone agonists, the fibroids actually can show rapid rebound growth. Some of the non-surgical interventions can provide longer term benefit, even if they may require re-intervention more frequently compared to surgical interventions.
For interventional radiology, we primarily focus on the procedures. We don't typically manage the medical therapy. These treatment approaches are cultivated more by gynecology or other clinicians.
When it comes to interventional radiology treatment for uterine fibroids in your day-to-day practices, which you've talked a lot about today, what has been your experience in working with Nurse Practitioners overall and where do they, should they or could they potentially add even more value?
Dr. Boone: Nurse practitioners play an integral role on the team and, I think, they provide a lot of value. They have an important role in teaching settings, were they provide continuity of care. They can also greatly impact with teaching of trainees.
In teaching settings, there's a substantial turnover of trainees because -- and this includes residents, medical students, in some cases fellows -- they're rotating between different hospitals every few weeks. Even at the end of the year, the most senior residents, the most experience trainees, leave to go to new jobs. Nurse practitioners on the IR team are a critical source of continuity and consistency for patients and for the rest of the team because they spend the most time on the service and they know the team members well. They also know how to get things done efficiently and really know the system.
They've also honed the skills that trainees, particularly junior residents, are learning. In my experience, I first learned to place and remove tunneled catheters and bone marrow biopsies by spending the day with a physician assistant and a nurse practitioner. Both from the educational standpoint and also consistent, efficient care standpoint, having NPs and PAs on our team is hugely valuable.
Emphasizing that role in teaching is highly valuable. I would encourage nurse practitioners on an IR team with trainees to take ownership of teaching a particular skill or a certain topic, because they're going to bring a different perspective and that's extremely valuable.
Another arena where there's a lot of value, is in the informed consent and patient education portion of patient care. Interventional radiology is not the most familiar medical field for a lot of people. Interventional radiologists also perform a wide array of procedures and they can be very different. Even treatments for the same problem, uterine artery embolization and MRI-guided focused ultrasound, are very different procedures in terms of how they're actually performed.
For example, if you mentioned surgery to most people, there is some idea of what that entails and who performs it. But if you say embolization to most people, they may not entirely understand all those components. For a patient to sufficiently be informed and able to consent, they do need to understand not only their disease and the treatment being offered, but also the risks, the benefits, and the alternatives. They need to understand what to expect from the procedure.
Doing this well can take a substantial amount of time, but it is important. From a physician standpoint, that entails balancing. Along with performing the procedures and reviewing patient imaging as well as other clinical duties this is very challenging. Nurse practitioners can really leverage their expertise in patient communication and education to fill in those knowledge gaps and best serve the patient while also helping the IR service. These are just two of many areas in which NPs can be highly valuable to an IR practice.
1. Kröncke T, David M. MR-Guided Focused Ultrasound in Fibroid Treatment – Results of the 4th Radiological-Gynecological Expert Meeting. Fortschr Röntgenstr. 2019;191(07):626-629. doi:10.1055/a-0884-3143
2. Sridhar D, Kohi M. Updates on MR-Guided Focused Ultrasound for Symptomatic Uterine Fibroids. Semin intervent Radiol. 2018;35(01):017-022. doi:10.1055/s-0038-1636516
3. Kohi MP, Spies JB. Updates on Uterine Artery Embolization. Semin intervent Radiol. 2018;35(1):48-55. doi:10.1055/s-0038-1636521
4. Dariushnia SR, Nikolic B, Stokes LS, Spies JB. Quality Improvement Guidelines for Uterine Artery Embolization for Symptomatic Leiomyomata. Journal of Vascular and Interventional Radiology. 2014;25(11):1737-1747. doi:10.1016/j.jvir.2014.08.029
5. Wise A. Facing invasive treatments for uterine fibroids, Black women advocate for better care. NPR. https://www.npr.org/sections/health-shots/2022/04/10/1087483675/facing-invasive-treatments-for-uterine-fibroids-black-women-advocate-for-better-. Published April 10, 2022. Accessed June 9, 2022.
6. http://fyra.io. SIR Survey Shows Public Awareness Shortcomings for UFE as Treatment Option for Uterine Fibroids. Endovascular Today. Accessed June 9, 2022. https://evtoday.com/news/sir-survey-shows-public-awareness-shortcomings-for-ufe-as-treatment-option-for-uterine-fibroids
Interventional approaches are being used as a standard of care more and more to provide image-guided techniques to perform minimally invasive procedures. With this being said, what are some indications and best practices used with interventional radiology for the treatment of uterine fibroids?
Dr. Boone: Interventional radiologists offer minimally invasive non-surgical treatment options for the management of symptomatic uterine fibroids. These approaches include uterine artery embolization or UAE. It may also be called uterine fibroid embolization or UFE. In this procedure, the uterine arteries are embolized with permanent embolic particles to block blood flow to the fibroids.
The goal of this treatment is to shrink the fibroids. It usually leads to a gradual shrinkage of fibroids and can also be particularly effective for reducing bleeding from fibroids. This procedure has been around for more than 20 years and has a lot of data describing its safety and efficacy.
Another treatment, which is non-invasive, but some interventional radiologists offer, is magnetic resonance-guided focused ultrasound. This might also be called high intensity focused ultrasound or HIFU. In this treatment, MRI is used to direct high intensity ultrasound waves onto the fibroid. This focused application of these high intensity ultrasound waves generates heat and leads to coagulative necrosis of the fibroid.
This procedure is newer than uterine artery embolization, but it has some benefits of avoiding ionizing radiation. Although, it can have longer procedure times. For both procedures, the indications are symptomatic uterine fibroids.
The symptoms we're concerned about include menorrhagia, which can result in anemia. There are also “bulk” symptoms, related to the actual bulk of the fibroids, which can cause bladder or bowel dysfunction. Some patients also have protrusion of their abdomen, dysmenorrhea, and infertility.
The goal is to help reduce those symptoms. The Society for Interventional Radiology has published best practices. For expected outcomes, with the uterine artery embolization, it is 50% to 60% reduction in the size of fibroid of the fibroids themselves, 40% to 50% reduction in the size of the uterus, 88% to 92% of reduction of the bulk symptoms.
Every consultation should discuss the range of treatment options—the medical, surgical, and non-surgical or interventional. I wanted to point out that there is a real need for this. The Society for Interventional Radiology commissioned a poll in 2017 of patients–women who had been diagnosed with uterine fibroids—and found that 44% of patients noted never hearing of uterine artery embolization. Eleven percent of these patients believed that hysterectomy was their only treatment option. Further, a recent article from NPR noted concerns about disparities in which women of color, particularly Black women, were not offered or made aware of more minimally invasive options during consultations. Very broad patient education about the range of treatment options is important.
In addition, we want to consider other differential diagnoses that patients may have, such as adenomyosis or rare malignancies. Leiomyosarcoma can present with similar symptoms to uterine fibroids or can even coexist with uterine fibroids. In the case of leiomyosarcoma, the treatment pathway may be completely different, and we don't want to undertreat or delay diagnosis. Other considerations that can have bearing on the selection of treatment can be the number and the size of the fibroids.
To help with the decision-making process, these patients need a complete workup. We want to get lab tests. We want to also make sure they have a complete gynecologic evaluation, which includes an ultrasound and an MRI. Particularly, contrast-enhanced MRI has great accuracy for evaluating fibroid location because we’re imaging the entire pelvis. We can see where everything is and map out our target fibroids.
We can also see the enhancement characteristics of the fibroids. Some fibroids are not just supplied by uterine arteries but ovarian arteries, which can affect the efficacy of the treatment and even some of the risks of the treatment.
What is your role and particularly what is the role of the Nurse Practitioner when thinking about diagnosis and treatment and how do you and the nurse practitioner work together?
Dr. Boone: I would say the specific roles for the physicians and nurse practitioners on an interventional radiology team can vary with a lot of different factors. It could depend on the practice setting, such as, whether you're in a busy academic center or in a small private practice. It can depend on the types of cases we're doing. Even some of the local regulations of the institution and state can come into play. The roles tend to be laid out and specified by the supervising physician based on this context.
For example, ideally, all of that work up and planning is happening in that clinic setting before the patient even comes down to the suite for the procedure. In this setting, nurse practitioners can provide a significant role in obtaining the data that we need. They'll perform the history and physical exam, which helps the team learn about the patients. It helps answer relevant questions: What symptoms is the patient having? What are their wishes for the procedure? What are the things they're hoping to avoid or hoping to get from having the procedure done? They review for those relevant labs and imaging, and in order to recognize the information we don’t have.
The next step is developing the assessment and plan which is usually done in conjunction with the interventional radiologist. This is especially important with new patients. Once that assessment and plan are determined, the nurse practitioner can be helpful in explaining the process in depth to the patient and their family or caregivers while they're in the clinic.
Another important role for nurse practitioners in this setting is the consent. I can talk a little bit more about that later, but informed consent is critical. It can be a pretty extensive discussion, especially if we want to talk about this wide range of treatment options. So that is substantial value added by the nurse practitioner.
The other important role is the follow up visits, which may be almost completely independently by a nurse practitioner. They see patients post-procedure, evaluating how they’re doing and what's changed. This is critical because we need to determine: 1. Have we gotten the result that we want? 2. Do we want to give more time to see changes? and; 3. Do we need to do another procedure? We also want to follow these patients and their response to treatment to look out for something concerning that might raise concern for malignancy, such as the fibroid continuing to grow rapidly. Those follow up visits are also a critical role for NPs.
In the inpatient setting, the attending and senior interventional radiology residents may actually determine the roles and tasks the other team members are going to perform to help the IR service run smoothly. And typically, nurse practitioners and also physician assistants will share many of those responsibilities of running that interventional radiology service outside of the procedure room.
There are also cases where nurse practitioners and physician assistants can have a dedicated role in performing certain procedures. Personally, I've seen physician assistants in these cases, where they were our dedicated bone marrow biopsy providers. Throughout the day, they would do all the bone marrow biopsy cases. Another example I saw was placement of vascular access catheters, whether for ports or dialysis. NPs see many patients throughout the day and perform these procedures. This is helpful because these are very popular procedures and are needed. While those are being done, it frees up time for the other members of the team to do other, more time-consuming, procedures as well.
In all cases, we work closely together. We're sharing this responsibility of patient care. We communicate frequently and it's a valuable team dynamic. NPs are fantastic team members
Dr. Boone, you talked about the treatments and how you work together with NPs. Can you touch on the interventional procedures and the value or benefit over conservative treatments and drugs, particularly, where you receive support or recommendations from nurse practitioners at this stage?
Dr. Boone: Regarding more conservative treatment, there’s expectant management where the patients may not want to undergo an intervention at that time. You’re following the patient and watching for possible worsening of symptoms that may lead to a change in management.
There’s also medical management, which generally gets broken down into hormonal or non-hormonal medications. Among these, there's a lot of different drugs that are available. Among the more frequently used hormonal therapies would be gonadotropin-releasing hormone agonists.
The non-hormonal therapies such as, NSAIDs, or procoagulation medications, like tranexamic acid, are more targeted at symptom control. Particularly, these target the abnormal uterine bleeding and the pain.
For these therapies, the limitations can be side-effect profiles. Sometimes these side effects are just not acceptable to patients. Hormonal therapies like the gonadotropin-releasing hormone agonists create this hypoestrogenic state. Patients may not like having the menopause-like symptoms.
Additionally, medications are more short-term in their benefit. For example, with the cessation of gonadotropin-releasing hormone agonists, the fibroids actually can show rapid rebound growth. Some of the non-surgical interventions can provide longer term benefit, even if they may require re-intervention more frequently compared to surgical interventions.
For interventional radiology, we primarily focus on the procedures. We don't typically manage the medical therapy. These treatment approaches are cultivated more by gynecology or other clinicians.
When it comes to interventional radiology treatment for uterine fibroids in your day-to-day practices, which you've talked a lot about today, what has been your experience in working with Nurse Practitioners overall and where do they, should they or could they potentially add even more value?
Dr. Boone: Nurse practitioners play an integral role on the team and, I think, they provide a lot of value. They have an important role in teaching settings, were they provide continuity of care. They can also greatly impact with teaching of trainees.
In teaching settings, there's a substantial turnover of trainees because -- and this includes residents, medical students, in some cases fellows -- they're rotating between different hospitals every few weeks. Even at the end of the year, the most senior residents, the most experience trainees, leave to go to new jobs. Nurse practitioners on the IR team are a critical source of continuity and consistency for patients and for the rest of the team because they spend the most time on the service and they know the team members well. They also know how to get things done efficiently and really know the system.
They've also honed the skills that trainees, particularly junior residents, are learning. In my experience, I first learned to place and remove tunneled catheters and bone marrow biopsies by spending the day with a physician assistant and a nurse practitioner. Both from the educational standpoint and also consistent, efficient care standpoint, having NPs and PAs on our team is hugely valuable.
Emphasizing that role in teaching is highly valuable. I would encourage nurse practitioners on an IR team with trainees to take ownership of teaching a particular skill or a certain topic, because they're going to bring a different perspective and that's extremely valuable.
Another arena where there's a lot of value, is in the informed consent and patient education portion of patient care. Interventional radiology is not the most familiar medical field for a lot of people. Interventional radiologists also perform a wide array of procedures and they can be very different. Even treatments for the same problem, uterine artery embolization and MRI-guided focused ultrasound, are very different procedures in terms of how they're actually performed.
For example, if you mentioned surgery to most people, there is some idea of what that entails and who performs it. But if you say embolization to most people, they may not entirely understand all those components. For a patient to sufficiently be informed and able to consent, they do need to understand not only their disease and the treatment being offered, but also the risks, the benefits, and the alternatives. They need to understand what to expect from the procedure.
Doing this well can take a substantial amount of time, but it is important. From a physician standpoint, that entails balancing. Along with performing the procedures and reviewing patient imaging as well as other clinical duties this is very challenging. Nurse practitioners can really leverage their expertise in patient communication and education to fill in those knowledge gaps and best serve the patient while also helping the IR service. These are just two of many areas in which NPs can be highly valuable to an IR practice.
Interventional approaches are being used as a standard of care more and more to provide image-guided techniques to perform minimally invasive procedures. With this being said, what are some indications and best practices used with interventional radiology for the treatment of uterine fibroids?
Dr. Boone: Interventional radiologists offer minimally invasive non-surgical treatment options for the management of symptomatic uterine fibroids. These approaches include uterine artery embolization or UAE. It may also be called uterine fibroid embolization or UFE. In this procedure, the uterine arteries are embolized with permanent embolic particles to block blood flow to the fibroids.
The goal of this treatment is to shrink the fibroids. It usually leads to a gradual shrinkage of fibroids and can also be particularly effective for reducing bleeding from fibroids. This procedure has been around for more than 20 years and has a lot of data describing its safety and efficacy.
Another treatment, which is non-invasive, but some interventional radiologists offer, is magnetic resonance-guided focused ultrasound. This might also be called high intensity focused ultrasound or HIFU. In this treatment, MRI is used to direct high intensity ultrasound waves onto the fibroid. This focused application of these high intensity ultrasound waves generates heat and leads to coagulative necrosis of the fibroid.
This procedure is newer than uterine artery embolization, but it has some benefits of avoiding ionizing radiation. Although, it can have longer procedure times. For both procedures, the indications are symptomatic uterine fibroids.
The symptoms we're concerned about include menorrhagia, which can result in anemia. There are also “bulk” symptoms, related to the actual bulk of the fibroids, which can cause bladder or bowel dysfunction. Some patients also have protrusion of their abdomen, dysmenorrhea, and infertility.
The goal is to help reduce those symptoms. The Society for Interventional Radiology has published best practices. For expected outcomes, with the uterine artery embolization, it is 50% to 60% reduction in the size of fibroid of the fibroids themselves, 40% to 50% reduction in the size of the uterus, 88% to 92% of reduction of the bulk symptoms.
Every consultation should discuss the range of treatment options—the medical, surgical, and non-surgical or interventional. I wanted to point out that there is a real need for this. The Society for Interventional Radiology commissioned a poll in 2017 of patients–women who had been diagnosed with uterine fibroids—and found that 44% of patients noted never hearing of uterine artery embolization. Eleven percent of these patients believed that hysterectomy was their only treatment option. Further, a recent article from NPR noted concerns about disparities in which women of color, particularly Black women, were not offered or made aware of more minimally invasive options during consultations. Very broad patient education about the range of treatment options is important.
In addition, we want to consider other differential diagnoses that patients may have, such as adenomyosis or rare malignancies. Leiomyosarcoma can present with similar symptoms to uterine fibroids or can even coexist with uterine fibroids. In the case of leiomyosarcoma, the treatment pathway may be completely different, and we don't want to undertreat or delay diagnosis. Other considerations that can have bearing on the selection of treatment can be the number and the size of the fibroids.
To help with the decision-making process, these patients need a complete workup. We want to get lab tests. We want to also make sure they have a complete gynecologic evaluation, which includes an ultrasound and an MRI. Particularly, contrast-enhanced MRI has great accuracy for evaluating fibroid location because we’re imaging the entire pelvis. We can see where everything is and map out our target fibroids.
We can also see the enhancement characteristics of the fibroids. Some fibroids are not just supplied by uterine arteries but ovarian arteries, which can affect the efficacy of the treatment and even some of the risks of the treatment.
What is your role and particularly what is the role of the Nurse Practitioner when thinking about diagnosis and treatment and how do you and the nurse practitioner work together?
Dr. Boone: I would say the specific roles for the physicians and nurse practitioners on an interventional radiology team can vary with a lot of different factors. It could depend on the practice setting, such as, whether you're in a busy academic center or in a small private practice. It can depend on the types of cases we're doing. Even some of the local regulations of the institution and state can come into play. The roles tend to be laid out and specified by the supervising physician based on this context.
For example, ideally, all of that work up and planning is happening in that clinic setting before the patient even comes down to the suite for the procedure. In this setting, nurse practitioners can provide a significant role in obtaining the data that we need. They'll perform the history and physical exam, which helps the team learn about the patients. It helps answer relevant questions: What symptoms is the patient having? What are their wishes for the procedure? What are the things they're hoping to avoid or hoping to get from having the procedure done? They review for those relevant labs and imaging, and in order to recognize the information we don’t have.
The next step is developing the assessment and plan which is usually done in conjunction with the interventional radiologist. This is especially important with new patients. Once that assessment and plan are determined, the nurse practitioner can be helpful in explaining the process in depth to the patient and their family or caregivers while they're in the clinic.
Another important role for nurse practitioners in this setting is the consent. I can talk a little bit more about that later, but informed consent is critical. It can be a pretty extensive discussion, especially if we want to talk about this wide range of treatment options. So that is substantial value added by the nurse practitioner.
The other important role is the follow up visits, which may be almost completely independently by a nurse practitioner. They see patients post-procedure, evaluating how they’re doing and what's changed. This is critical because we need to determine: 1. Have we gotten the result that we want? 2. Do we want to give more time to see changes? and; 3. Do we need to do another procedure? We also want to follow these patients and their response to treatment to look out for something concerning that might raise concern for malignancy, such as the fibroid continuing to grow rapidly. Those follow up visits are also a critical role for NPs.
In the inpatient setting, the attending and senior interventional radiology residents may actually determine the roles and tasks the other team members are going to perform to help the IR service run smoothly. And typically, nurse practitioners and also physician assistants will share many of those responsibilities of running that interventional radiology service outside of the procedure room.
There are also cases where nurse practitioners and physician assistants can have a dedicated role in performing certain procedures. Personally, I've seen physician assistants in these cases, where they were our dedicated bone marrow biopsy providers. Throughout the day, they would do all the bone marrow biopsy cases. Another example I saw was placement of vascular access catheters, whether for ports or dialysis. NPs see many patients throughout the day and perform these procedures. This is helpful because these are very popular procedures and are needed. While those are being done, it frees up time for the other members of the team to do other, more time-consuming, procedures as well.
In all cases, we work closely together. We're sharing this responsibility of patient care. We communicate frequently and it's a valuable team dynamic. NPs are fantastic team members
Dr. Boone, you talked about the treatments and how you work together with NPs. Can you touch on the interventional procedures and the value or benefit over conservative treatments and drugs, particularly, where you receive support or recommendations from nurse practitioners at this stage?
Dr. Boone: Regarding more conservative treatment, there’s expectant management where the patients may not want to undergo an intervention at that time. You’re following the patient and watching for possible worsening of symptoms that may lead to a change in management.
There’s also medical management, which generally gets broken down into hormonal or non-hormonal medications. Among these, there's a lot of different drugs that are available. Among the more frequently used hormonal therapies would be gonadotropin-releasing hormone agonists.
The non-hormonal therapies such as, NSAIDs, or procoagulation medications, like tranexamic acid, are more targeted at symptom control. Particularly, these target the abnormal uterine bleeding and the pain.
For these therapies, the limitations can be side-effect profiles. Sometimes these side effects are just not acceptable to patients. Hormonal therapies like the gonadotropin-releasing hormone agonists create this hypoestrogenic state. Patients may not like having the menopause-like symptoms.
Additionally, medications are more short-term in their benefit. For example, with the cessation of gonadotropin-releasing hormone agonists, the fibroids actually can show rapid rebound growth. Some of the non-surgical interventions can provide longer term benefit, even if they may require re-intervention more frequently compared to surgical interventions.
For interventional radiology, we primarily focus on the procedures. We don't typically manage the medical therapy. These treatment approaches are cultivated more by gynecology or other clinicians.
When it comes to interventional radiology treatment for uterine fibroids in your day-to-day practices, which you've talked a lot about today, what has been your experience in working with Nurse Practitioners overall and where do they, should they or could they potentially add even more value?
Dr. Boone: Nurse practitioners play an integral role on the team and, I think, they provide a lot of value. They have an important role in teaching settings, were they provide continuity of care. They can also greatly impact with teaching of trainees.
In teaching settings, there's a substantial turnover of trainees because -- and this includes residents, medical students, in some cases fellows -- they're rotating between different hospitals every few weeks. Even at the end of the year, the most senior residents, the most experience trainees, leave to go to new jobs. Nurse practitioners on the IR team are a critical source of continuity and consistency for patients and for the rest of the team because they spend the most time on the service and they know the team members well. They also know how to get things done efficiently and really know the system.
They've also honed the skills that trainees, particularly junior residents, are learning. In my experience, I first learned to place and remove tunneled catheters and bone marrow biopsies by spending the day with a physician assistant and a nurse practitioner. Both from the educational standpoint and also consistent, efficient care standpoint, having NPs and PAs on our team is hugely valuable.
Emphasizing that role in teaching is highly valuable. I would encourage nurse practitioners on an IR team with trainees to take ownership of teaching a particular skill or a certain topic, because they're going to bring a different perspective and that's extremely valuable.
Another arena where there's a lot of value, is in the informed consent and patient education portion of patient care. Interventional radiology is not the most familiar medical field for a lot of people. Interventional radiologists also perform a wide array of procedures and they can be very different. Even treatments for the same problem, uterine artery embolization and MRI-guided focused ultrasound, are very different procedures in terms of how they're actually performed.
For example, if you mentioned surgery to most people, there is some idea of what that entails and who performs it. But if you say embolization to most people, they may not entirely understand all those components. For a patient to sufficiently be informed and able to consent, they do need to understand not only their disease and the treatment being offered, but also the risks, the benefits, and the alternatives. They need to understand what to expect from the procedure.
Doing this well can take a substantial amount of time, but it is important. From a physician standpoint, that entails balancing. Along with performing the procedures and reviewing patient imaging as well as other clinical duties this is very challenging. Nurse practitioners can really leverage their expertise in patient communication and education to fill in those knowledge gaps and best serve the patient while also helping the IR service. These are just two of many areas in which NPs can be highly valuable to an IR practice.
1. Kröncke T, David M. MR-Guided Focused Ultrasound in Fibroid Treatment – Results of the 4th Radiological-Gynecological Expert Meeting. Fortschr Röntgenstr. 2019;191(07):626-629. doi:10.1055/a-0884-3143
2. Sridhar D, Kohi M. Updates on MR-Guided Focused Ultrasound for Symptomatic Uterine Fibroids. Semin intervent Radiol. 2018;35(01):017-022. doi:10.1055/s-0038-1636516
3. Kohi MP, Spies JB. Updates on Uterine Artery Embolization. Semin intervent Radiol. 2018;35(1):48-55. doi:10.1055/s-0038-1636521
4. Dariushnia SR, Nikolic B, Stokes LS, Spies JB. Quality Improvement Guidelines for Uterine Artery Embolization for Symptomatic Leiomyomata. Journal of Vascular and Interventional Radiology. 2014;25(11):1737-1747. doi:10.1016/j.jvir.2014.08.029
5. Wise A. Facing invasive treatments for uterine fibroids, Black women advocate for better care. NPR. https://www.npr.org/sections/health-shots/2022/04/10/1087483675/facing-invasive-treatments-for-uterine-fibroids-black-women-advocate-for-better-. Published April 10, 2022. Accessed June 9, 2022.
6. http://fyra.io. SIR Survey Shows Public Awareness Shortcomings for UFE as Treatment Option for Uterine Fibroids. Endovascular Today. Accessed June 9, 2022. https://evtoday.com/news/sir-survey-shows-public-awareness-shortcomings-for-ufe-as-treatment-option-for-uterine-fibroids
1. Kröncke T, David M. MR-Guided Focused Ultrasound in Fibroid Treatment – Results of the 4th Radiological-Gynecological Expert Meeting. Fortschr Röntgenstr. 2019;191(07):626-629. doi:10.1055/a-0884-3143
2. Sridhar D, Kohi M. Updates on MR-Guided Focused Ultrasound for Symptomatic Uterine Fibroids. Semin intervent Radiol. 2018;35(01):017-022. doi:10.1055/s-0038-1636516
3. Kohi MP, Spies JB. Updates on Uterine Artery Embolization. Semin intervent Radiol. 2018;35(1):48-55. doi:10.1055/s-0038-1636521
4. Dariushnia SR, Nikolic B, Stokes LS, Spies JB. Quality Improvement Guidelines for Uterine Artery Embolization for Symptomatic Leiomyomata. Journal of Vascular and Interventional Radiology. 2014;25(11):1737-1747. doi:10.1016/j.jvir.2014.08.029
5. Wise A. Facing invasive treatments for uterine fibroids, Black women advocate for better care. NPR. https://www.npr.org/sections/health-shots/2022/04/10/1087483675/facing-invasive-treatments-for-uterine-fibroids-black-women-advocate-for-better-. Published April 10, 2022. Accessed June 9, 2022.
6. http://fyra.io. SIR Survey Shows Public Awareness Shortcomings for UFE as Treatment Option for Uterine Fibroids. Endovascular Today. Accessed June 9, 2022. https://evtoday.com/news/sir-survey-shows-public-awareness-shortcomings-for-ufe-as-treatment-option-for-uterine-fibroids
Tampon shortage linked to supply chain, inflation issues
Social media users have posted about bare shelves and higher costs for months, marking the latest products to face stress under global supply chain concerns after baby formula, cars, and appliances.
Other menstrual products have increased in price as well because of inflation, according to Bloomberg News. The average price for a package of menstrual pads has increased about 8% this year, and the price of a box of tampons has increased about 10%.
Andre Schulten, the chief financial officer for Procter & Gamble, which makes and sells 4.5 billion boxes of Tampax each year, said on a recent earnings call that it has been “costly and highly volatile” to acquire the raw materials needed for production.
Raw materials such as cotton, rayon, and plastic, for instance, have been used to produce personal protective gear during the pandemic, which has led to shortages. The cost of transportation for consumer goods has also nearly tripled, and pandemic policies at ports have led to shipping delays.
Edgewell Personal Care, which makes the brands Playtex and o.b., has had a severe staff shortage at its Delaware facility where tampons are made, according to Time. The FDA has classified tampons as class II medical devices, which require certain quality-control regulations and qualified workers on the assembly line, the news outlet reported.
Representatives for CVS and Walgreens confirmed that they’ve had shortages in recent weeks, according to The Washington Post. Procter & Gamble said it is working with retail partners to make feminine care products more available.
“We understand it is frustrating for consumers when they can’t find what they need,” the company told the newspaper. “We can assure you this is a temporary situation.”
Kimberly-Clark, which makes U by Kotex tampons, told the Post that it “has not experienced a product or supply shortage” in the United States, saying it is “working closely with our retail partners to keep shelves stocked.”
But the shortage may grow worse as the year goes on and the peak season for shipping approaches, the newspaper reported.
“Capacity is only going to get tighter as we move toward the end of the year,” Vaughn Moore, chief executive of AIT Worldwide Logistics, told the Post.
While the situation is being straightened out, gynecologists have recommended against extending supply at home by wearing tampons for longer stretches of time, according to The New York Times. Toxic shock syndrome is a rare but potentially fatal condition that can occur when tampons are worn for more than 8 hours.
There are other options, such as reusable menstrual pads, period underwear, and menstrual cups and discs, the Times reported. But some of these may be less appealing to use, or they may cost too much.
A version of this article first appeared on WebMD.com.
Social media users have posted about bare shelves and higher costs for months, marking the latest products to face stress under global supply chain concerns after baby formula, cars, and appliances.
Other menstrual products have increased in price as well because of inflation, according to Bloomberg News. The average price for a package of menstrual pads has increased about 8% this year, and the price of a box of tampons has increased about 10%.
Andre Schulten, the chief financial officer for Procter & Gamble, which makes and sells 4.5 billion boxes of Tampax each year, said on a recent earnings call that it has been “costly and highly volatile” to acquire the raw materials needed for production.
Raw materials such as cotton, rayon, and plastic, for instance, have been used to produce personal protective gear during the pandemic, which has led to shortages. The cost of transportation for consumer goods has also nearly tripled, and pandemic policies at ports have led to shipping delays.
Edgewell Personal Care, which makes the brands Playtex and o.b., has had a severe staff shortage at its Delaware facility where tampons are made, according to Time. The FDA has classified tampons as class II medical devices, which require certain quality-control regulations and qualified workers on the assembly line, the news outlet reported.
Representatives for CVS and Walgreens confirmed that they’ve had shortages in recent weeks, according to The Washington Post. Procter & Gamble said it is working with retail partners to make feminine care products more available.
“We understand it is frustrating for consumers when they can’t find what they need,” the company told the newspaper. “We can assure you this is a temporary situation.”
Kimberly-Clark, which makes U by Kotex tampons, told the Post that it “has not experienced a product or supply shortage” in the United States, saying it is “working closely with our retail partners to keep shelves stocked.”
But the shortage may grow worse as the year goes on and the peak season for shipping approaches, the newspaper reported.
“Capacity is only going to get tighter as we move toward the end of the year,” Vaughn Moore, chief executive of AIT Worldwide Logistics, told the Post.
While the situation is being straightened out, gynecologists have recommended against extending supply at home by wearing tampons for longer stretches of time, according to The New York Times. Toxic shock syndrome is a rare but potentially fatal condition that can occur when tampons are worn for more than 8 hours.
There are other options, such as reusable menstrual pads, period underwear, and menstrual cups and discs, the Times reported. But some of these may be less appealing to use, or they may cost too much.
A version of this article first appeared on WebMD.com.
Social media users have posted about bare shelves and higher costs for months, marking the latest products to face stress under global supply chain concerns after baby formula, cars, and appliances.
Other menstrual products have increased in price as well because of inflation, according to Bloomberg News. The average price for a package of menstrual pads has increased about 8% this year, and the price of a box of tampons has increased about 10%.
Andre Schulten, the chief financial officer for Procter & Gamble, which makes and sells 4.5 billion boxes of Tampax each year, said on a recent earnings call that it has been “costly and highly volatile” to acquire the raw materials needed for production.
Raw materials such as cotton, rayon, and plastic, for instance, have been used to produce personal protective gear during the pandemic, which has led to shortages. The cost of transportation for consumer goods has also nearly tripled, and pandemic policies at ports have led to shipping delays.
Edgewell Personal Care, which makes the brands Playtex and o.b., has had a severe staff shortage at its Delaware facility where tampons are made, according to Time. The FDA has classified tampons as class II medical devices, which require certain quality-control regulations and qualified workers on the assembly line, the news outlet reported.
Representatives for CVS and Walgreens confirmed that they’ve had shortages in recent weeks, according to The Washington Post. Procter & Gamble said it is working with retail partners to make feminine care products more available.
“We understand it is frustrating for consumers when they can’t find what they need,” the company told the newspaper. “We can assure you this is a temporary situation.”
Kimberly-Clark, which makes U by Kotex tampons, told the Post that it “has not experienced a product or supply shortage” in the United States, saying it is “working closely with our retail partners to keep shelves stocked.”
But the shortage may grow worse as the year goes on and the peak season for shipping approaches, the newspaper reported.
“Capacity is only going to get tighter as we move toward the end of the year,” Vaughn Moore, chief executive of AIT Worldwide Logistics, told the Post.
While the situation is being straightened out, gynecologists have recommended against extending supply at home by wearing tampons for longer stretches of time, according to The New York Times. Toxic shock syndrome is a rare but potentially fatal condition that can occur when tampons are worn for more than 8 hours.
There are other options, such as reusable menstrual pads, period underwear, and menstrual cups and discs, the Times reported. But some of these may be less appealing to use, or they may cost too much.
A version of this article first appeared on WebMD.com.
Hormonal contraceptives protective against suicide?
Contrary to previous analyses, new research suggests.
In a study of more than 800 women younger than age 50 who attempted suicide and more than 3,000 age-matched peers, results showed those who took hormonal contraceptives had a 27% reduced risk for attempted suicide.
Further analysis showed this was confined to women without a history of psychiatric illness and the reduction in risk rose to 43% among those who took combined hormonal contraceptives rather than progestin-only versions.
The protective effect against attempted suicide increased further to 46% if ethinyl estradiol (EE)–containing preparations were used. Moreover, the beneficial effect of contraceptive use increased over time.
The main message is the “current use of hormonal contraceptives is not associated with an increased risk of attempted suicide in our population,” study presenter Elena Toffol, MD, PhD, department of public health, University of Helsinki, told meeting attendees at the European Psychiatric Association 2022 Congress.
Age range differences
Dr. Toffol said there could be “several reasons” why the results are different from those in previous studies, including that the researchers included a “larger age range.” She noted it is known that “older women have a lower rate of attempted suicide and use different types of contraceptives.”
Dr. Toffol said in an interview that, although it’s “hard to estimate any causality” because this is an observational study, it is “tempting to speculate, and it is plausible, that hormones partly play a role with some, but not all, women being more sensitive to hormonal influences.”
However, the results “may also reflect life choices or a protective life status; for example, more stable relationships or more conscious and health-focused behaviors,” she said.
“It may also be that the underlying characteristics of women who are prescribed or opt for certain types of contraceptives are somehow related to their suicidal risk,” she added.
In 2019, the global age-standardized suicide rate was 9.0 per 100,000, which translates into more than 700,000 deaths every year, Dr. Toffol noted.
However, she emphasized the World Health Organization has calculated that, for every adult who dies by suicide, more than 20 people attempt suicide. In addition, data from the U.S. Centers for Disease Control and Prevention indicate that attempted suicides are three times more common among young women than in men.
“What are the reasons for this gender gap?” Dr. Toffol asked during her presentation.
“It is known that the major risk factor for suicidal behavior is a psychiatric disorder, and in particular depression and mood disorders. And depression and mood disorders are more common in women than in men,” she said.
However, there is also “growing interest into the role of biological factors” in the risk for suicide, including hormones and hormonal contraception. Some studies have also suggested that there is an increased risk for depression and “both completed and attempted suicide” after starting hormonal contraception.
Dr. Toffol added that about 70% of European women use some form of contraception and, among Finnish women, 40% choose a hormonal contraceptive.
Nested analysis
The researchers conducted a nested case-control analysis combining 2017 national prescription data on 587,823 women aged 15-49 years with information from general and primary healthcare registers for the years 2018 to 2019.
They were able to identify 818 cases of attempted suicide among the women. These were matched 4:1 with 3,272 age-matched healthy women who acted as the control group. Use of hormonal contraceptives in the previous 180 days was determined for the whole cohort.
Among users of hormonal contraceptives, there were 344 attempted suicides in 2017, at an incidence rate of 0.59 per 1,000 person-years. This compared with 474 attempted suicides among nonusers, at an incidence rate of 0.81 per 1000 person-years.
Kaplan-Meier analysis showed there was a significant difference in rates for attempted suicide among hormonal contraceptive users versus nonusers, at an incidence rate ratio of 0.73 (P < .0001) – and the difference increased over time.
In addition, the incidence of attempted suicide decreased with increasing age, with the highest incidence rate in women aged 15-19 years (1.62 per 1,000 person-years).
Conditional logistic regression analysis that controlled for education, marital status, chronic disease, recent psychiatric hospitalization, and current use of psychotropic medication showed hormonal contraceptive use was not linked to an increased risk of attempted suicide overall, at an odds ratio of 0.79 (95% confidence interval, 0.56-1.11).
However, when they looked specifically at women without a history of psychiatric illness, the association became significant, at an OR of 0.73 for attempted suicide among hormonal contraceptive users (95% CI, 0.58-0.91), while the relationship remained nonsignificant in women with a history of psychiatric disorders.
Further analysis suggested the significant association was confined to women taking combined hormonal contraceptives, at an OR of 0.57 for suicide attempt versus nonusers (95% CI, 0.44-0.75), and those use EE-containing preparations (OR, 0.54; 95% CI, 0.40-0.73).
There was a suggestion in the data that hormonal contraceptives containing desogestrel or drospirenone alongside EE may offer the greatest reduction in attempted suicide risk, but that did not survive multivariate analysis.
Dr. Toffol also noted that they were not able to capture data on use of intrauterine devices in their analysis.
“There is a growing number of municipalities in Finland that are providing free-of-charge contraception to young women” that is often an intrauterine device, she said. The researchers hope to include these women in a future analysis.
‘Age matters’
Commenting on the findings, Alexis C. Edwards, PhD, Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, said the current study’s findings “made a lot of sense.” Dr. Edwards wasn’t involved with this study but conducted a previous study of 216,702 Swedish women aged 15-22 years that showed use of combination or progestin-only oral contraceptives was associated with an increased risk for suicidal behavior.
She agreed with Dr. Toffol that the “much larger age range” in the new study may have played a role in showing the opposite result.
“The trajectory that we saw if we had been able to continue following the women for longer – which we couldn’t, due to limitations of the registries – [was that] using hormonal contraceptives was going to end up being protective, so I do think that it matters what age you’re looking at,” she said.
Dr. Edwards noted the takeaway from both studies “is that, even if there is a slight increase in risk from using hormonal contraceptives, it’s short lived and it’s probably specific to young women, which is important.”
She suggested the hormonal benefit from extended contraceptive use could come from the regulation of mood, as it offers a “more stable hormonal course than what their body might be putting them through in the absence of using the pill.”
Overall, it is “really lovely to see very well-executed studies on this, providing more empirical evidence on this question, because it is something that’s relevant to anyone who’s potentially going to be using hormonal contraception,” Dr. Edwards said.
Clinical implications?
Andrea Fiorillo, MD, PhD, department of psychiatry, University of Campania “Luigi Vanvitelli,” Naples, Italy, said in a press release that the “striking” findings of the current study need “careful evaluation.”
They also need to be replicated in “different cohorts of women and controlled for the impact of several psychosocial stressors, such as economic upheavals, social insecurity, and uncertainty due to the COVID pandemic,” said Dr. Fiorillo, who was not involved with the research.
Nevertheless, she believes the “clinical implications of the study are obvious and may help to destigmatize the use of hormonal contraceptives.”
The study was funded by the Jane and Aatos Erkko Foundation, the Avohoidon Tsukimis äätiö (Foundation for Primary Care Research), the Yrj ö Jahnsson Foundation, and the Finnish Cultural Foundation. No relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
Contrary to previous analyses, new research suggests.
In a study of more than 800 women younger than age 50 who attempted suicide and more than 3,000 age-matched peers, results showed those who took hormonal contraceptives had a 27% reduced risk for attempted suicide.
Further analysis showed this was confined to women without a history of psychiatric illness and the reduction in risk rose to 43% among those who took combined hormonal contraceptives rather than progestin-only versions.
The protective effect against attempted suicide increased further to 46% if ethinyl estradiol (EE)–containing preparations were used. Moreover, the beneficial effect of contraceptive use increased over time.
The main message is the “current use of hormonal contraceptives is not associated with an increased risk of attempted suicide in our population,” study presenter Elena Toffol, MD, PhD, department of public health, University of Helsinki, told meeting attendees at the European Psychiatric Association 2022 Congress.
Age range differences
Dr. Toffol said there could be “several reasons” why the results are different from those in previous studies, including that the researchers included a “larger age range.” She noted it is known that “older women have a lower rate of attempted suicide and use different types of contraceptives.”
Dr. Toffol said in an interview that, although it’s “hard to estimate any causality” because this is an observational study, it is “tempting to speculate, and it is plausible, that hormones partly play a role with some, but not all, women being more sensitive to hormonal influences.”
However, the results “may also reflect life choices or a protective life status; for example, more stable relationships or more conscious and health-focused behaviors,” she said.
“It may also be that the underlying characteristics of women who are prescribed or opt for certain types of contraceptives are somehow related to their suicidal risk,” she added.
In 2019, the global age-standardized suicide rate was 9.0 per 100,000, which translates into more than 700,000 deaths every year, Dr. Toffol noted.
However, she emphasized the World Health Organization has calculated that, for every adult who dies by suicide, more than 20 people attempt suicide. In addition, data from the U.S. Centers for Disease Control and Prevention indicate that attempted suicides are three times more common among young women than in men.
“What are the reasons for this gender gap?” Dr. Toffol asked during her presentation.
“It is known that the major risk factor for suicidal behavior is a psychiatric disorder, and in particular depression and mood disorders. And depression and mood disorders are more common in women than in men,” she said.
However, there is also “growing interest into the role of biological factors” in the risk for suicide, including hormones and hormonal contraception. Some studies have also suggested that there is an increased risk for depression and “both completed and attempted suicide” after starting hormonal contraception.
Dr. Toffol added that about 70% of European women use some form of contraception and, among Finnish women, 40% choose a hormonal contraceptive.
Nested analysis
The researchers conducted a nested case-control analysis combining 2017 national prescription data on 587,823 women aged 15-49 years with information from general and primary healthcare registers for the years 2018 to 2019.
They were able to identify 818 cases of attempted suicide among the women. These were matched 4:1 with 3,272 age-matched healthy women who acted as the control group. Use of hormonal contraceptives in the previous 180 days was determined for the whole cohort.
Among users of hormonal contraceptives, there were 344 attempted suicides in 2017, at an incidence rate of 0.59 per 1,000 person-years. This compared with 474 attempted suicides among nonusers, at an incidence rate of 0.81 per 1000 person-years.
Kaplan-Meier analysis showed there was a significant difference in rates for attempted suicide among hormonal contraceptive users versus nonusers, at an incidence rate ratio of 0.73 (P < .0001) – and the difference increased over time.
In addition, the incidence of attempted suicide decreased with increasing age, with the highest incidence rate in women aged 15-19 years (1.62 per 1,000 person-years).
Conditional logistic regression analysis that controlled for education, marital status, chronic disease, recent psychiatric hospitalization, and current use of psychotropic medication showed hormonal contraceptive use was not linked to an increased risk of attempted suicide overall, at an odds ratio of 0.79 (95% confidence interval, 0.56-1.11).
However, when they looked specifically at women without a history of psychiatric illness, the association became significant, at an OR of 0.73 for attempted suicide among hormonal contraceptive users (95% CI, 0.58-0.91), while the relationship remained nonsignificant in women with a history of psychiatric disorders.
Further analysis suggested the significant association was confined to women taking combined hormonal contraceptives, at an OR of 0.57 for suicide attempt versus nonusers (95% CI, 0.44-0.75), and those use EE-containing preparations (OR, 0.54; 95% CI, 0.40-0.73).
There was a suggestion in the data that hormonal contraceptives containing desogestrel or drospirenone alongside EE may offer the greatest reduction in attempted suicide risk, but that did not survive multivariate analysis.
Dr. Toffol also noted that they were not able to capture data on use of intrauterine devices in their analysis.
“There is a growing number of municipalities in Finland that are providing free-of-charge contraception to young women” that is often an intrauterine device, she said. The researchers hope to include these women in a future analysis.
‘Age matters’
Commenting on the findings, Alexis C. Edwards, PhD, Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, said the current study’s findings “made a lot of sense.” Dr. Edwards wasn’t involved with this study but conducted a previous study of 216,702 Swedish women aged 15-22 years that showed use of combination or progestin-only oral contraceptives was associated with an increased risk for suicidal behavior.
She agreed with Dr. Toffol that the “much larger age range” in the new study may have played a role in showing the opposite result.
“The trajectory that we saw if we had been able to continue following the women for longer – which we couldn’t, due to limitations of the registries – [was that] using hormonal contraceptives was going to end up being protective, so I do think that it matters what age you’re looking at,” she said.
Dr. Edwards noted the takeaway from both studies “is that, even if there is a slight increase in risk from using hormonal contraceptives, it’s short lived and it’s probably specific to young women, which is important.”
She suggested the hormonal benefit from extended contraceptive use could come from the regulation of mood, as it offers a “more stable hormonal course than what their body might be putting them through in the absence of using the pill.”
Overall, it is “really lovely to see very well-executed studies on this, providing more empirical evidence on this question, because it is something that’s relevant to anyone who’s potentially going to be using hormonal contraception,” Dr. Edwards said.
Clinical implications?
Andrea Fiorillo, MD, PhD, department of psychiatry, University of Campania “Luigi Vanvitelli,” Naples, Italy, said in a press release that the “striking” findings of the current study need “careful evaluation.”
They also need to be replicated in “different cohorts of women and controlled for the impact of several psychosocial stressors, such as economic upheavals, social insecurity, and uncertainty due to the COVID pandemic,” said Dr. Fiorillo, who was not involved with the research.
Nevertheless, she believes the “clinical implications of the study are obvious and may help to destigmatize the use of hormonal contraceptives.”
The study was funded by the Jane and Aatos Erkko Foundation, the Avohoidon Tsukimis äätiö (Foundation for Primary Care Research), the Yrj ö Jahnsson Foundation, and the Finnish Cultural Foundation. No relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
Contrary to previous analyses, new research suggests.
In a study of more than 800 women younger than age 50 who attempted suicide and more than 3,000 age-matched peers, results showed those who took hormonal contraceptives had a 27% reduced risk for attempted suicide.
Further analysis showed this was confined to women without a history of psychiatric illness and the reduction in risk rose to 43% among those who took combined hormonal contraceptives rather than progestin-only versions.
The protective effect against attempted suicide increased further to 46% if ethinyl estradiol (EE)–containing preparations were used. Moreover, the beneficial effect of contraceptive use increased over time.
The main message is the “current use of hormonal contraceptives is not associated with an increased risk of attempted suicide in our population,” study presenter Elena Toffol, MD, PhD, department of public health, University of Helsinki, told meeting attendees at the European Psychiatric Association 2022 Congress.
Age range differences
Dr. Toffol said there could be “several reasons” why the results are different from those in previous studies, including that the researchers included a “larger age range.” She noted it is known that “older women have a lower rate of attempted suicide and use different types of contraceptives.”
Dr. Toffol said in an interview that, although it’s “hard to estimate any causality” because this is an observational study, it is “tempting to speculate, and it is plausible, that hormones partly play a role with some, but not all, women being more sensitive to hormonal influences.”
However, the results “may also reflect life choices or a protective life status; for example, more stable relationships or more conscious and health-focused behaviors,” she said.
“It may also be that the underlying characteristics of women who are prescribed or opt for certain types of contraceptives are somehow related to their suicidal risk,” she added.
In 2019, the global age-standardized suicide rate was 9.0 per 100,000, which translates into more than 700,000 deaths every year, Dr. Toffol noted.
However, she emphasized the World Health Organization has calculated that, for every adult who dies by suicide, more than 20 people attempt suicide. In addition, data from the U.S. Centers for Disease Control and Prevention indicate that attempted suicides are three times more common among young women than in men.
“What are the reasons for this gender gap?” Dr. Toffol asked during her presentation.
“It is known that the major risk factor for suicidal behavior is a psychiatric disorder, and in particular depression and mood disorders. And depression and mood disorders are more common in women than in men,” she said.
However, there is also “growing interest into the role of biological factors” in the risk for suicide, including hormones and hormonal contraception. Some studies have also suggested that there is an increased risk for depression and “both completed and attempted suicide” after starting hormonal contraception.
Dr. Toffol added that about 70% of European women use some form of contraception and, among Finnish women, 40% choose a hormonal contraceptive.
Nested analysis
The researchers conducted a nested case-control analysis combining 2017 national prescription data on 587,823 women aged 15-49 years with information from general and primary healthcare registers for the years 2018 to 2019.
They were able to identify 818 cases of attempted suicide among the women. These were matched 4:1 with 3,272 age-matched healthy women who acted as the control group. Use of hormonal contraceptives in the previous 180 days was determined for the whole cohort.
Among users of hormonal contraceptives, there were 344 attempted suicides in 2017, at an incidence rate of 0.59 per 1,000 person-years. This compared with 474 attempted suicides among nonusers, at an incidence rate of 0.81 per 1000 person-years.
Kaplan-Meier analysis showed there was a significant difference in rates for attempted suicide among hormonal contraceptive users versus nonusers, at an incidence rate ratio of 0.73 (P < .0001) – and the difference increased over time.
In addition, the incidence of attempted suicide decreased with increasing age, with the highest incidence rate in women aged 15-19 years (1.62 per 1,000 person-years).
Conditional logistic regression analysis that controlled for education, marital status, chronic disease, recent psychiatric hospitalization, and current use of psychotropic medication showed hormonal contraceptive use was not linked to an increased risk of attempted suicide overall, at an odds ratio of 0.79 (95% confidence interval, 0.56-1.11).
However, when they looked specifically at women without a history of psychiatric illness, the association became significant, at an OR of 0.73 for attempted suicide among hormonal contraceptive users (95% CI, 0.58-0.91), while the relationship remained nonsignificant in women with a history of psychiatric disorders.
Further analysis suggested the significant association was confined to women taking combined hormonal contraceptives, at an OR of 0.57 for suicide attempt versus nonusers (95% CI, 0.44-0.75), and those use EE-containing preparations (OR, 0.54; 95% CI, 0.40-0.73).
There was a suggestion in the data that hormonal contraceptives containing desogestrel or drospirenone alongside EE may offer the greatest reduction in attempted suicide risk, but that did not survive multivariate analysis.
Dr. Toffol also noted that they were not able to capture data on use of intrauterine devices in their analysis.
“There is a growing number of municipalities in Finland that are providing free-of-charge contraception to young women” that is often an intrauterine device, she said. The researchers hope to include these women in a future analysis.
‘Age matters’
Commenting on the findings, Alexis C. Edwards, PhD, Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, said the current study’s findings “made a lot of sense.” Dr. Edwards wasn’t involved with this study but conducted a previous study of 216,702 Swedish women aged 15-22 years that showed use of combination or progestin-only oral contraceptives was associated with an increased risk for suicidal behavior.
She agreed with Dr. Toffol that the “much larger age range” in the new study may have played a role in showing the opposite result.
“The trajectory that we saw if we had been able to continue following the women for longer – which we couldn’t, due to limitations of the registries – [was that] using hormonal contraceptives was going to end up being protective, so I do think that it matters what age you’re looking at,” she said.
Dr. Edwards noted the takeaway from both studies “is that, even if there is a slight increase in risk from using hormonal contraceptives, it’s short lived and it’s probably specific to young women, which is important.”
She suggested the hormonal benefit from extended contraceptive use could come from the regulation of mood, as it offers a “more stable hormonal course than what their body might be putting them through in the absence of using the pill.”
Overall, it is “really lovely to see very well-executed studies on this, providing more empirical evidence on this question, because it is something that’s relevant to anyone who’s potentially going to be using hormonal contraception,” Dr. Edwards said.
Clinical implications?
Andrea Fiorillo, MD, PhD, department of psychiatry, University of Campania “Luigi Vanvitelli,” Naples, Italy, said in a press release that the “striking” findings of the current study need “careful evaluation.”
They also need to be replicated in “different cohorts of women and controlled for the impact of several psychosocial stressors, such as economic upheavals, social insecurity, and uncertainty due to the COVID pandemic,” said Dr. Fiorillo, who was not involved with the research.
Nevertheless, she believes the “clinical implications of the study are obvious and may help to destigmatize the use of hormonal contraceptives.”
The study was funded by the Jane and Aatos Erkko Foundation, the Avohoidon Tsukimis äätiö (Foundation for Primary Care Research), the Yrj ö Jahnsson Foundation, and the Finnish Cultural Foundation. No relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
FROM EPA 2022
Surgeons may underestimate recovery from incontinence operation
Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.
The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.
“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.
Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.
The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”
Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”
Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.
For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.
Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.
As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.
The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.
Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
Essential information for patient planning
Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.
Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.
She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”
Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.
“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.
The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.
Dr. Wang and Dr. Boyd reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.
The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.
“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.
Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.
The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”
Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”
Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.
For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.
Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.
As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.
The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.
Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
Essential information for patient planning
Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.
Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.
She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”
Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.
“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.
The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.
Dr. Wang and Dr. Boyd reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.
The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.
“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.
Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.
The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”
Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”
Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.
For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.
Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.
As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.
The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.
Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
Essential information for patient planning
Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.
Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.
She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”
Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.
“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.
The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.
Dr. Wang and Dr. Boyd reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AUGS 2022