Women's Health

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients.

Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues.

“Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN).

“Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes.

To address this knowledge gap, Dr. Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN.

This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress.

Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively.

Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively.

Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis.

“New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr. Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Courtney Rhoades, DO, MBA, FACOG, medical director of labor and delivery and assistant professor of obstetrics and gynecology at the University of Florida, Jacksonville, suggested that the meta-analysis supports the safety of intermittent auscultation, but the results may not be entirely applicable to real-world practice.

“It is hard, in practice, to draw the same conclusion that they do in the study that the newer methods may cause too many emergency C-sections because our fetal monitoring equipment, methodology for interpretation, ability to do emergency C-sections and maternal risk factors have changed in the last 50 years,” Dr. Rhoades said. “Continuous fetal monitoring gives more data points during labor, and with more data points, there are more opportunities to interpret and act – either correctly or incorrectly. As they state in the study, the decision to do a C-section is multifactorial.”

Dr. Rhoades, who recently authored a textbook chapter on intrapartum monitoring and fetal assessment, recommended that intermittent auscultation be reserved for low-risk patients.

“The American College of Obstetricians and Gynecologists has endorsed intermittent auscultation for low-risk pregnancies and this study affirms their support,” Dr. Rhoades said. “Women with a low-risk pregnancy can benefit from intermittent auscultation because it allows them more autonomy and movement during labor so it should be offered to our low-risk patients.”

Dr. Al Wattar reported a personal Academic Clinical Lectureship from the U.K. National Health Institute of Research. Dr. Khan disclosed funding from the Beatriz Galindo Program Grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients.

Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues.

“Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN).

“Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes.

To address this knowledge gap, Dr. Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN.

This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress.

Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively.

Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively.

Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis.

“New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr. Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Courtney Rhoades, DO, MBA, FACOG, medical director of labor and delivery and assistant professor of obstetrics and gynecology at the University of Florida, Jacksonville, suggested that the meta-analysis supports the safety of intermittent auscultation, but the results may not be entirely applicable to real-world practice.

“It is hard, in practice, to draw the same conclusion that they do in the study that the newer methods may cause too many emergency C-sections because our fetal monitoring equipment, methodology for interpretation, ability to do emergency C-sections and maternal risk factors have changed in the last 50 years,” Dr. Rhoades said. “Continuous fetal monitoring gives more data points during labor, and with more data points, there are more opportunities to interpret and act – either correctly or incorrectly. As they state in the study, the decision to do a C-section is multifactorial.”

Dr. Rhoades, who recently authored a textbook chapter on intrapartum monitoring and fetal assessment, recommended that intermittent auscultation be reserved for low-risk patients.

“The American College of Obstetricians and Gynecologists has endorsed intermittent auscultation for low-risk pregnancies and this study affirms their support,” Dr. Rhoades said. “Women with a low-risk pregnancy can benefit from intermittent auscultation because it allows them more autonomy and movement during labor so it should be offered to our low-risk patients.”

Dr. Al Wattar reported a personal Academic Clinical Lectureship from the U.K. National Health Institute of Research. Dr. Khan disclosed funding from the Beatriz Galindo Program Grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.

For intrapartum fetal surveillance, the old way may be the best way, according to a meta-analysis involving more than 118,000 patients.

Intermittent auscultation with a Pinard stethoscope and handheld Doppler was associated with a significantly lower risk of emergency cesarean deliveries than newer monitoring techniques without jeopardizing maternal or neonatal outcomes, reported lead author Bassel H. Al Wattar, MD, PhD, of University of Warwick, Coventry, England, and University College London Hospitals, and colleagues.

“Over the last 50 years, several newer surveillance methods have been evaluated, with varied uptake in practice,” the investigators wrote in the Canadian Medical Association Journal, noting that cardiotocography (CTG) is the most common method for high-risk pregnancies, typically coupled with at least one other modality, such as fetal scalp pH analysis (FBS), fetal pulse oximetry (FPO), or fetal heart electrocardiogram (STAN).

“Despite extensive investment in clinical research, the overall effectiveness of such methods in improving maternal and neonatal outcomes remains debatable as stillbirth rates have plateaued worldwide, while cesarean delivery rates continue to rise,” the investigators wrote. Previous meta-analyses have relied upon head-to-head comparisons of monitoring techniques and did not take into account effects on maternal and neonatal outcomes.

To address this knowledge gap, Dr. Al Wattar and colleagues conducted the present systematic review and meta-analysis, ultimately including 33 trials with 118,863 women who underwent intrapartum fetal surveillance, dating back to 1976. Ten surveillance types were evaluated, including intermittent auscultation with Pinard stethoscope and handheld Doppler, CTG with or without computer-aided decision models (cCTG), and CTG or cCTG combined with one or two other techniques, such as FBS, FPO, and STAN.

This revealed that intermittent auscultation outperformed all other techniques in terms of emergency cesarean deliveries and emergency cesarean deliveries because of fetal distress.

Specifically, intermittent auscultation significantly reduced risk of emergency cesarean deliveries, compared with CTG (relative risk, 0.83; 95% confidence interval, 0.72-0.97), CTG-FBS (RR, 0.71; 95% CI, 0.63-0.80), CTG-lactate (RR, 0.77; 95% CI, 0.64-0.92), and FPO-CTG-FBS (RR, 0.81; 95% CI, 0.67-0.99). Conversely, compared with IA, STAN-CTG-FBS and cCTG-FBS raised risk of emergency cesarean deliveries by 17% and 21%, respectively.

Compared with other modalities, the superiority of intermittent auscultation was even more pronounced in terms of emergency cesarean deliveries because of fetal distress. Intermittent auscultation reduced risk by 43%, compared with CTG, 66% compared with CTG-FBS, 58%, compared with FPO-CTG, and 17%, compared with FPO-CTG-FBS. Conversely, compared with intermittent auscultation, STAN-CTG and cCTG-FBS increased risk of emergency cesarean deliveries because of fetal distress by 39% and 80%, respectively.

Further analysis showed that all types of surveillance had similar effects on neonatal outcomes, such as admission to neonatal unit and neonatal acidemia. Although a combination of STAN or FPO with CTG-FBS “seemed to improve the likelihood of reducing adverse neonatal outcomes,” the investigators noted that these differences were not significant in network meta­-analysis.

“New fetal surveillance methods did not improve neonatal outcomes or reduce unnecessary maternal interventions,” Dr. Al Wattar and colleagues concluded. “Further evidence is needed to evaluate the effects of fetal pulse oximetry and fetal heart electrocardiography in labor.”

Courtney Rhoades, DO, MBA, FACOG, medical director of labor and delivery and assistant professor of obstetrics and gynecology at the University of Florida, Jacksonville, suggested that the meta-analysis supports the safety of intermittent auscultation, but the results may not be entirely applicable to real-world practice.

“It is hard, in practice, to draw the same conclusion that they do in the study that the newer methods may cause too many emergency C-sections because our fetal monitoring equipment, methodology for interpretation, ability to do emergency C-sections and maternal risk factors have changed in the last 50 years,” Dr. Rhoades said. “Continuous fetal monitoring gives more data points during labor, and with more data points, there are more opportunities to interpret and act – either correctly or incorrectly. As they state in the study, the decision to do a C-section is multifactorial.”

Dr. Rhoades, who recently authored a textbook chapter on intrapartum monitoring and fetal assessment, recommended that intermittent auscultation be reserved for low-risk patients.

“The American College of Obstetricians and Gynecologists has endorsed intermittent auscultation for low-risk pregnancies and this study affirms their support,” Dr. Rhoades said. “Women with a low-risk pregnancy can benefit from intermittent auscultation because it allows them more autonomy and movement during labor so it should be offered to our low-risk patients.”

Dr. Al Wattar reported a personal Academic Clinical Lectureship from the U.K. National Health Institute of Research. Dr. Khan disclosed funding from the Beatriz Galindo Program Grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government.

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

The Food and Drug Administration has lifted in-person dispensing requirements for mifepristone when used for medical termination of early pregnancy.  
In an April 12, 2021, letter to the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine, acting commissioner of food and drugs Janet Woodcock stated that the FDA would exercise discretion to permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.  
The decision follows a trial period of suspension of the in-person dispensing requirement in response to safety concerns for patients as well as providers associated with in-person clinic visits during the COVID-19 pandemic. The Center for Drug Evaluation and Research reviewed safety and clinical outcomes data on mifepristone use when prescriptions were handled by mail or mail-order pharmacy and found that "the small number of adverse events reported to FDA during the COVID-19 public health emergency [PHE] provide no indication that any program deviation or noncompliance with the mifepristone [Risk Evaluation and Mitigation Strategy] program contributed to the reported adverse events," according to the letter. The analysis covers Mifeprex and the approved generic, mifepristone tablets, both 200-mg doses. 
As long as other mifepristone REMS criteria are met, the FDA will continue to permit mail and mail-order prescriptions, according to the letter. 
"By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence - which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive," Maureen G. Phipps, MD, MPH, CEO of ACOG, said in a statement in response to the FDA decision.  
ACOG petitioned the FDA to suspend the in-person requirement to reduce the risk of transmission in the wake of the COVID-19 pandemic, given safety concerns and the potential impact on hard-hit communities, particularly communities of color, Dr. Phipps emphasized. Data from a review period with a suspension of the in-person requirement yielded no additional safety concerns with mifepristone use, and contributed to the FDA decision to lift the requirement. 
"Thanks to the FDA's intent to exercise discretion in enforcing the in-person dispensing requirement, those in need of an abortion or miscarriage management will be able to do so safety and effectively by acquiring mifepristone though the mail - just as they would any other medication with a similarly strong safety profile," said Dr. Phipps. "We are pleased to see mifepristone regulated on the basis of the scientific evidence during the pandemic, rather than political bias against comprehensive reproductive health care, and we look forward to working with policy makers to ensure this principle governs postpandemic care."  
CDER is communicating the decision to all approved application holders subject to the mifepristone REMS program, according to the letter.  
[email protected]

A novel therapy combining platelet-rich plasma (PRP) with follicle-stimulating hormone that is injected directly into the ovaries has the potential to restore ovarian function for women who experience early menopause, possibly allowing for pregnancy without the need for donor eggs.

“The resumption of ovarian function in our participants means women with early menopause could have the opportunity to pursue pregnancy through IVF [in vitro fertilization] using their own eggs,” the authors of the groundbreaking pilot study report.

In the small study, published online March 29 in Menopause, menstruation resumed within a mean of about 5 weeks for 11 of 12 patients with early menopause who were treated with the technique. One patient achieved a clinical pregnancy.

In commenting on the study, Stephanie S. Faubion, MD, medical director of the North American Menopause Society, was cautious in her interpretation, noting the need for more research in larger samples.

“Any pregnancy that results from a regenerative therapy is novel,” she told this news organization. “Still, we are a long way away from this being a standard therapy for women with premature ovarian insufficiency.”
 

Pilot study: Platelet-rich plasma combination with FSH

Early menopause is the cessation of ovarian function at or before the age of 45 years. It is estimated that 12.2% of women experience early menopause. For these women, currently, the only chance of becoming pregnant is with donor eggs.

PRP, an autologous plasma preparation containing more than 10 times the concentration of growth factors and active metabolites than normal plasma, has recently been shown to have the potential to restore the menstrual cycles in perimenopausal women, allowing IVF. It has also been shown to benefit women with premature ovarian insufficiency (POI). However, there have been few reports of pregnancies or live births.

Chao Chin Hsu, MD, PhD, of the National Taiwan University Hospital, Taipei, and colleagues investigated whether the combination of the activated PRP treatment with gondatrophins such as FSH could provide a more robust effect so as to sufficiently stimulate follicles. They used the intraovarian injection of the combination to treat a 38-year-old woman with POI.

The effort was successful, and the woman gave birth to healthy twins.

To further evaluate the approach, the authors conducted a pilot study involving 12 women with early menopause (mean age, 44.4 years) between November 2018 and November 2019.

The women received intraovarian injection with PRP prepared from 40 mL of autologous peripheral blood combined with recombinant FSH.

Following the treatment, 11 of the 12 women experienced resumption of menstruation within a mean of 37 days. For seven patients, menstruation resumed within a month; for three, it resumed within about 2 months; and for one, it resumed after approximately 3 months.

Of note, the menstrual cycles were mostly irregular, with an interval of about 45.6 days.

The women’s average serum FSH level dropped significantly from 70.5 IU/L at baseline to 26.2 IU/L within days of treatment, as did the average luteinizing hormone level (34.8 before and 14.3 IU/L after treatment), indicative of improved ovary function.

For six participants, 10 oocyte retrieval procedures were performed after a mean of about 2 months. Thirteen mature eggs were retrieved, and fertilization via intracytoplasmic sperm injection was attempted, resulting in 10 fertilized oocytes.

Cleavage-stage embryos were transferred into two of the participants. One achieved a clinical pregnancy, defined as a pregnancy that was confirmed by ultrasound and by the presence of a fetal heartbeat. The pregnancy ended in miscarriage at 7 weeks’ gestation.

The length of controlled ovarian stimulation necessary for follicle growth ranged from 8 to 14 days, which the authors note is similar to that seen with women of normal reproductive age.

“Although the use of PRP in reproductive medicine is considered experimental, we demonstrated the restoration of ovarian function in early menopausal women who adopted whole dimension subcortical ovarian injection of PRP/gonadotropin,” the authors write.

“Most remarkably, an early menopausal woman achieved pregnancy after the treatment followed by IVF with her mature ovulating follicle,” they report.
 

Mechanisms, caveats

The mechanisms thought to underlie the success of the approach include increases in ovarian vascularization and stromal cell proliferation and reductions in oxidative stress and cell death in ovaries, the authors explain.

Key caveats with the treatment include the fact that anesthesia and laparoscopy are required, and precise administration is required at 15 injection sites in 1-2 mm of the ovarian subcortical area, which can be difficult to achieve, Dr. Hsu said in an interview.

“If a new instrument could be developed in which physicians can carry out this treatment through a vaginal approach, like the transvaginal retrieval of eggs in IVF treatments,” the approach could become more acceptable, Dr. Hsu added.

The authors call for studies with larger sample sizes and say it will also be interesting to determine effects in different groups: For example, women with cancer who have undergone chemotherapy.

Dr. Faubion, who is director of the Mayo Clinic Women’s Health, Rochester, Minn., says the causes of early menopause could be important in determining the treatment’s efficacy.

“[The therapy’s] success may depend on the reason the woman experienced early menopause: For instance, due to chemotherapy, radiation, virus, autoimmune disease, genetic mutation, or other cause,” she said.

She also noted that cost could be an important factor.

“I don’t see a cost estimate, but it will be substantial,” she said. “So, even if the success rate improves as this technique is further studied, cost and the invasive nature of the treatment may prove to be substantial barriers to this therapy becoming mainstream,” she said.

The authors and Dr. Faubion have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A novel therapy combining platelet-rich plasma (PRP) with follicle-stimulating hormone that is injected directly into the ovaries has the potential to restore ovarian function for women who experience early menopause, possibly allowing for pregnancy without the need for donor eggs.

“The resumption of ovarian function in our participants means women with early menopause could have the opportunity to pursue pregnancy through IVF [in vitro fertilization] using their own eggs,” the authors of the groundbreaking pilot study report.

In the small study, published online March 29 in Menopause, menstruation resumed within a mean of about 5 weeks for 11 of 12 patients with early menopause who were treated with the technique. One patient achieved a clinical pregnancy.

In commenting on the study, Stephanie S. Faubion, MD, medical director of the North American Menopause Society, was cautious in her interpretation, noting the need for more research in larger samples.

“Any pregnancy that results from a regenerative therapy is novel,” she told this news organization. “Still, we are a long way away from this being a standard therapy for women with premature ovarian insufficiency.”
 

Pilot study: Platelet-rich plasma combination with FSH

Early menopause is the cessation of ovarian function at or before the age of 45 years. It is estimated that 12.2% of women experience early menopause. For these women, currently, the only chance of becoming pregnant is with donor eggs.

PRP, an autologous plasma preparation containing more than 10 times the concentration of growth factors and active metabolites than normal plasma, has recently been shown to have the potential to restore the menstrual cycles in perimenopausal women, allowing IVF. It has also been shown to benefit women with premature ovarian insufficiency (POI). However, there have been few reports of pregnancies or live births.

Chao Chin Hsu, MD, PhD, of the National Taiwan University Hospital, Taipei, and colleagues investigated whether the combination of the activated PRP treatment with gondatrophins such as FSH could provide a more robust effect so as to sufficiently stimulate follicles. They used the intraovarian injection of the combination to treat a 38-year-old woman with POI.

The effort was successful, and the woman gave birth to healthy twins.

To further evaluate the approach, the authors conducted a pilot study involving 12 women with early menopause (mean age, 44.4 years) between November 2018 and November 2019.

The women received intraovarian injection with PRP prepared from 40 mL of autologous peripheral blood combined with recombinant FSH.

Following the treatment, 11 of the 12 women experienced resumption of menstruation within a mean of 37 days. For seven patients, menstruation resumed within a month; for three, it resumed within about 2 months; and for one, it resumed after approximately 3 months.

Of note, the menstrual cycles were mostly irregular, with an interval of about 45.6 days.

The women’s average serum FSH level dropped significantly from 70.5 IU/L at baseline to 26.2 IU/L within days of treatment, as did the average luteinizing hormone level (34.8 before and 14.3 IU/L after treatment), indicative of improved ovary function.

For six participants, 10 oocyte retrieval procedures were performed after a mean of about 2 months. Thirteen mature eggs were retrieved, and fertilization via intracytoplasmic sperm injection was attempted, resulting in 10 fertilized oocytes.

Cleavage-stage embryos were transferred into two of the participants. One achieved a clinical pregnancy, defined as a pregnancy that was confirmed by ultrasound and by the presence of a fetal heartbeat. The pregnancy ended in miscarriage at 7 weeks’ gestation.

The length of controlled ovarian stimulation necessary for follicle growth ranged from 8 to 14 days, which the authors note is similar to that seen with women of normal reproductive age.

“Although the use of PRP in reproductive medicine is considered experimental, we demonstrated the restoration of ovarian function in early menopausal women who adopted whole dimension subcortical ovarian injection of PRP/gonadotropin,” the authors write.

“Most remarkably, an early menopausal woman achieved pregnancy after the treatment followed by IVF with her mature ovulating follicle,” they report.
 

Mechanisms, caveats

The mechanisms thought to underlie the success of the approach include increases in ovarian vascularization and stromal cell proliferation and reductions in oxidative stress and cell death in ovaries, the authors explain.

Key caveats with the treatment include the fact that anesthesia and laparoscopy are required, and precise administration is required at 15 injection sites in 1-2 mm of the ovarian subcortical area, which can be difficult to achieve, Dr. Hsu said in an interview.

“If a new instrument could be developed in which physicians can carry out this treatment through a vaginal approach, like the transvaginal retrieval of eggs in IVF treatments,” the approach could become more acceptable, Dr. Hsu added.

The authors call for studies with larger sample sizes and say it will also be interesting to determine effects in different groups: For example, women with cancer who have undergone chemotherapy.

Dr. Faubion, who is director of the Mayo Clinic Women’s Health, Rochester, Minn., says the causes of early menopause could be important in determining the treatment’s efficacy.

“[The therapy’s] success may depend on the reason the woman experienced early menopause: For instance, due to chemotherapy, radiation, virus, autoimmune disease, genetic mutation, or other cause,” she said.

She also noted that cost could be an important factor.

“I don’t see a cost estimate, but it will be substantial,” she said. “So, even if the success rate improves as this technique is further studied, cost and the invasive nature of the treatment may prove to be substantial barriers to this therapy becoming mainstream,” she said.

The authors and Dr. Faubion have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A novel therapy combining platelet-rich plasma (PRP) with follicle-stimulating hormone that is injected directly into the ovaries has the potential to restore ovarian function for women who experience early menopause, possibly allowing for pregnancy without the need for donor eggs.

“The resumption of ovarian function in our participants means women with early menopause could have the opportunity to pursue pregnancy through IVF [in vitro fertilization] using their own eggs,” the authors of the groundbreaking pilot study report.

In the small study, published online March 29 in Menopause, menstruation resumed within a mean of about 5 weeks for 11 of 12 patients with early menopause who were treated with the technique. One patient achieved a clinical pregnancy.

In commenting on the study, Stephanie S. Faubion, MD, medical director of the North American Menopause Society, was cautious in her interpretation, noting the need for more research in larger samples.

“Any pregnancy that results from a regenerative therapy is novel,” she told this news organization. “Still, we are a long way away from this being a standard therapy for women with premature ovarian insufficiency.”
 

Pilot study: Platelet-rich plasma combination with FSH

Early menopause is the cessation of ovarian function at or before the age of 45 years. It is estimated that 12.2% of women experience early menopause. For these women, currently, the only chance of becoming pregnant is with donor eggs.

PRP, an autologous plasma preparation containing more than 10 times the concentration of growth factors and active metabolites than normal plasma, has recently been shown to have the potential to restore the menstrual cycles in perimenopausal women, allowing IVF. It has also been shown to benefit women with premature ovarian insufficiency (POI). However, there have been few reports of pregnancies or live births.

Chao Chin Hsu, MD, PhD, of the National Taiwan University Hospital, Taipei, and colleagues investigated whether the combination of the activated PRP treatment with gondatrophins such as FSH could provide a more robust effect so as to sufficiently stimulate follicles. They used the intraovarian injection of the combination to treat a 38-year-old woman with POI.

The effort was successful, and the woman gave birth to healthy twins.

To further evaluate the approach, the authors conducted a pilot study involving 12 women with early menopause (mean age, 44.4 years) between November 2018 and November 2019.

The women received intraovarian injection with PRP prepared from 40 mL of autologous peripheral blood combined with recombinant FSH.

Following the treatment, 11 of the 12 women experienced resumption of menstruation within a mean of 37 days. For seven patients, menstruation resumed within a month; for three, it resumed within about 2 months; and for one, it resumed after approximately 3 months.

Of note, the menstrual cycles were mostly irregular, with an interval of about 45.6 days.

The women’s average serum FSH level dropped significantly from 70.5 IU/L at baseline to 26.2 IU/L within days of treatment, as did the average luteinizing hormone level (34.8 before and 14.3 IU/L after treatment), indicative of improved ovary function.

For six participants, 10 oocyte retrieval procedures were performed after a mean of about 2 months. Thirteen mature eggs were retrieved, and fertilization via intracytoplasmic sperm injection was attempted, resulting in 10 fertilized oocytes.

Cleavage-stage embryos were transferred into two of the participants. One achieved a clinical pregnancy, defined as a pregnancy that was confirmed by ultrasound and by the presence of a fetal heartbeat. The pregnancy ended in miscarriage at 7 weeks’ gestation.

The length of controlled ovarian stimulation necessary for follicle growth ranged from 8 to 14 days, which the authors note is similar to that seen with women of normal reproductive age.

“Although the use of PRP in reproductive medicine is considered experimental, we demonstrated the restoration of ovarian function in early menopausal women who adopted whole dimension subcortical ovarian injection of PRP/gonadotropin,” the authors write.

“Most remarkably, an early menopausal woman achieved pregnancy after the treatment followed by IVF with her mature ovulating follicle,” they report.
 

Mechanisms, caveats

The mechanisms thought to underlie the success of the approach include increases in ovarian vascularization and stromal cell proliferation and reductions in oxidative stress and cell death in ovaries, the authors explain.

Key caveats with the treatment include the fact that anesthesia and laparoscopy are required, and precise administration is required at 15 injection sites in 1-2 mm of the ovarian subcortical area, which can be difficult to achieve, Dr. Hsu said in an interview.

“If a new instrument could be developed in which physicians can carry out this treatment through a vaginal approach, like the transvaginal retrieval of eggs in IVF treatments,” the approach could become more acceptable, Dr. Hsu added.

The authors call for studies with larger sample sizes and say it will also be interesting to determine effects in different groups: For example, women with cancer who have undergone chemotherapy.

Dr. Faubion, who is director of the Mayo Clinic Women’s Health, Rochester, Minn., says the causes of early menopause could be important in determining the treatment’s efficacy.

“[The therapy’s] success may depend on the reason the woman experienced early menopause: For instance, due to chemotherapy, radiation, virus, autoimmune disease, genetic mutation, or other cause,” she said.

She also noted that cost could be an important factor.

“I don’t see a cost estimate, but it will be substantial,” she said. “So, even if the success rate improves as this technique is further studied, cost and the invasive nature of the treatment may prove to be substantial barriers to this therapy becoming mainstream,” she said.

The authors and Dr. Faubion have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.

Antonio_Diaz/iStock/via Getty Images

Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.

In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.

A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.

The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
 

Short meal-to-bed time shows strongest association

A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.

“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.

The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
 

Behavioral intervention may benefit pregnant women

The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”

The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.

Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).

The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.

A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.

Antonio_Diaz/iStock/via Getty Images

Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.

In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.

A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.

The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
 

Short meal-to-bed time shows strongest association

A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.

“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.

The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
 

Behavioral intervention may benefit pregnant women

The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”

The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.

Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).

The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.

A shorter period between eating and going to sleep increased the risk of GERD during pregnancy by approximately 12%, according to data from 400 women.

Antonio_Diaz/iStock/via Getty Images

Gastroesophageal reflux disease (GERD) is a common condition in pregnancy because of changes in gastrointestinal motility caused by hormonal changes, and a short meal-to-bed time (MTBT) also has been associated with increased GERD symptoms, but data on the impact of MTBT on GERD in pregnant women in particular are lacking, wrote Duc T. Quach, MD, of the University of Medicine and Pharmacy in Ho Chi Minh City, Vietnam, and colleagues.

In a cross-sectional study published in the Journal of Clinical Gastroenterology, the researchers identified 400 pregnant women aged 18 years and older in various stages of pregnancy who were seen at a single hospital in Vietnam. A short MTBT was defined as going to bed 2 hours or less after eating. Primary outcomes were GERD, defined as troublesome heartburn and/or regurgitation at least once a week, and reflux-related insomnia, defined as trouble initiating or maintaining nighttime sleep. Participants also reported the number of days of troublesome reflux symptoms and frequency of reflux-related insomnia over the last 7 days.

A total of 154 participants had a diagnosis of GERD, for an overall prevalence of 38.5%, similar to that seen in GERD studies of GERD and pregnancy, the researchers noted, and of those with GERD, 20 participants (13.0%) reported reflux-related insomnia.

The overall prevalence of heartburn, regurgitation, nausea with or without vomiting, and epigastric pain were 11.8%, 35.8%, 30.0%, and 5.5%, respectively. A total of 139 women reported reflux symptoms on at least 2 of the past 7 days, and 40 women reported both daytime and nighttime reflux symptoms.
 

Short meal-to-bed time shows strongest association

A short MTBT was the strongest predictor of GERD in multivariate analysis (odds ratio, 12.73; 95% confidence interval, 2.92-55.45; P = .001); previous history of reflux symptoms (OR, 9.05; 95% CI, 5.29-15.50; P < 001) and being in the third trimester versus first or second of pregnancy (OR, 1.66, 95% CI, 1.03-2.69; P = .039) also remained significant predictors in a multivariate analysis. In addition, nighttime short MTBT (but not daytime short MTBT) was the strongest risk factor for reflux-related insomnia (OR, 4.60), although alcohol consumption and a history of reflux-related symptoms also remained significant in multivariate analysis.

“Interestingly, the number of days during which reflux symptoms were experienced during the last 7 days sequentially increased across subgroups of participants with no short MTBT, either daytime or nighttime short MTBT, and with both daytime and nighttime MTBT,” the researchers wrote. At 4-7 days, none of the patients with no short MTBT reported reflux symptoms, compared with 7.5% of those with either daytime or nighttime MTBT and 20.9% of those with both daytime and nighttime MTBT.

The study findings were limited by several factors, including the inability to accurately record participants’ diets and the potential for overestimating the odds ratio of risk factors in patients with reflux-related insomnia because of the small numbers. However, the results support findings from previous studies and suggest that dietary modifications could provide a nonpharmacological treatment target for managing GERD in pregnant women, they concluded.
 

Behavioral intervention may benefit pregnant women

The study is important because heartburn and regurgitation are common challenges during pregnancy, Ziad F. Gellad, MD, of Duke University, Durham, N.C., said in an interview. “Understanding risk factors for these conditions can be helpful in designing behavioral and pharmaceutical therapeutic interventions.”

The link between short MTBT and increased risk for GERD is well-known, said Dr. Gellad. “Lengthening the time to laying supine after a meal is a common recommendation given to patients with GERD and is included in published GERD guidelines.” Although pregnant woman may have been excluded from trials on which the guidelines and recommendations are based, “it is reasonable to expect that findings would translate to this population that is generally higher risk for reflux,” he noted.

Dr. Gellad was interested to see the dose response between MTBT and reflux, with those patients having both daytime and nighttime short MTBT experiencing reflux more often than those with short MTBT in only one of those time periods (4-7 days vs. 1-3 days).

The key message for clinicians is that, for all individuals, pregnant or not, “avoiding late night meals and short meal-to-bed time is an appropriate behavioral intervention to recommend for patients with troublesome heartburn or regurgitation,” Dr. Gellad emphasized. However, more research is needed in some areas, “implementation studies would be helpful to understand how best to educate patients on behavioral modifications known to decrease reflux symptoms.”

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gellad had no relevant financial disclosures, but serves as a member of the GI & Hepatology News board of editors.

Preoperative endometrial thickness is associated with the risk of endometrial cancer in patients with endometrial intraepithelial neoplasia (EIN) and could potentially be used to guide lymph node assessment, according to investigators.

In a retrospective study of 378 patients who had hysterectomies for EIN, those with a preoperative endometrial stripe of 20 mm or greater were two times more likely to have endometrial cancer on final pathology, and those with an endometrial thickness of 15 mm or greater were 1.8 times more likely to have cancer.

“This data suggests that increasing endometrial thickness may be a useful preoperative marker to identify who’s at higher risk of concurrent endometrial cancer. It could also be considered a criterion for selectively using a sentinel lymph node algorithm in patients with a preoperative diagnosis of EIN. However, prospective studies are warranted to further establish this association,” said Devon Abt, MD, of Beth Israel Deaconess Medical Center in Boston.

She presented the data at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11103).
 

Risk of overtreatment

There are no clear consensus guidelines on lymph node assessment for patients with EIN, Dr. Abt noted. She pointed out that roughly 40% of patients with EIN are diagnosed with endometrial cancer. However, it’s usually low-stage, low-grade disease, and only about 10% of patients will have high-risk features that warrant lymph node evaluation.

“Typically, we identify patients with concurrent endometrial cancer based on intraoperative pathology, or frozen section,” Dr. Abt explained. “We then apply the Mayo criteria, which stratifies patients as high or low risk for lymph node metastasis based on pathologic criteria. ... This information helps guide our intraoperative decisions to perform, or not perform, pelvic and para-aortic lymphadenectomy.”

Dr. Abt noted, however, that “lymphadenectomy is not benign” and increases surgical time as well as the risk of complications.

Taking these factors into account, some centers have implemented routine sentinel lymph node algorithms for staging endometrial cancers, Dr. Abt said.

What she and her colleagues wanted to determine is if there is value in this practice. Should sentinel lymph node mapping and biopsy be offered routinely to all patients with a preoperative diagnosis of EIN?
 

Study details

Dr. Abt and colleagues conducted a retrospective, single-center study of 378 patients with EIN. Ultimately, 27% (n = 103) of the patients were diagnosed with endometrial cancer – 95% with stage 1a disease and 5% with stage 1b.

Increasing age, White race, and hypertension were significantly associated with the presence of endometrial cancer. Body mass index, parity, hormone therapy exposure, and baseline CA 125 were not.

The median preoperative endometrial thickness was 14 mm among patients with endometrial cancer and 11 mm in patients without cancer (P = .002).

Overall, 31% of the cancer cases were considered high risk for nodal metastases by Mayo criteria, but an endometrial stripe of 15 mm or higher increased the chance of being considered high risk.

The risk of cancer was 47% among patients with an endometrial stripe of at least 20 mm versus 21% among patients with a measurement below 15 mm.

Only 10 patients underwent lymph node evaluation, 5 with sentinel lymph node dissection and 5 with lymphadenectomy. Six of the 10 patients had endometrial cancer on final pathology, but none had positive lymph nodes.

“Given the low-grade and early-stage disease in this cohort, adherence to a routine sentinel lymph node algorithm in all patients with EIN would result in overtreatment,” Dr. Abt said.

Discussant Nicole Fleming, MD, of the University of Texas MD Anderson Cancer Center, Houston, said she would advocate for more selective use of sentinel lymph node biopsies in EIN as well.

Dr. Fleming said, in general, lymph node biopsy may be reasonable in settings where frozen sections are unreliable and the patient seems to be at high risk of invasive cancer. However, at academic centers with dedicated gynecologic pathologists, given the low risk of invasive cancer and the fact that lymph nodes “are probably not going to provide you a lot of useful therapeutic decision-making tools,” potentially eliminating sentinel lymph node biopsy might make sense, Dr. Fleming said.

Dr. Fleming disclosed relationships with Tesaro, Bristol-Myers Squibb, Pfizer, and GlaxoSmithKline. Dr. Abt reported having no relevant disclosures and did not report any study funding.

[email protected]

Preoperative endometrial thickness is associated with the risk of endometrial cancer in patients with endometrial intraepithelial neoplasia (EIN) and could potentially be used to guide lymph node assessment, according to investigators.

In a retrospective study of 378 patients who had hysterectomies for EIN, those with a preoperative endometrial stripe of 20 mm or greater were two times more likely to have endometrial cancer on final pathology, and those with an endometrial thickness of 15 mm or greater were 1.8 times more likely to have cancer.

“This data suggests that increasing endometrial thickness may be a useful preoperative marker to identify who’s at higher risk of concurrent endometrial cancer. It could also be considered a criterion for selectively using a sentinel lymph node algorithm in patients with a preoperative diagnosis of EIN. However, prospective studies are warranted to further establish this association,” said Devon Abt, MD, of Beth Israel Deaconess Medical Center in Boston.

She presented the data at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11103).
 

Risk of overtreatment

There are no clear consensus guidelines on lymph node assessment for patients with EIN, Dr. Abt noted. She pointed out that roughly 40% of patients with EIN are diagnosed with endometrial cancer. However, it’s usually low-stage, low-grade disease, and only about 10% of patients will have high-risk features that warrant lymph node evaluation.

“Typically, we identify patients with concurrent endometrial cancer based on intraoperative pathology, or frozen section,” Dr. Abt explained. “We then apply the Mayo criteria, which stratifies patients as high or low risk for lymph node metastasis based on pathologic criteria. ... This information helps guide our intraoperative decisions to perform, or not perform, pelvic and para-aortic lymphadenectomy.”

Dr. Abt noted, however, that “lymphadenectomy is not benign” and increases surgical time as well as the risk of complications.

Taking these factors into account, some centers have implemented routine sentinel lymph node algorithms for staging endometrial cancers, Dr. Abt said.

What she and her colleagues wanted to determine is if there is value in this practice. Should sentinel lymph node mapping and biopsy be offered routinely to all patients with a preoperative diagnosis of EIN?
 

Study details

Dr. Abt and colleagues conducted a retrospective, single-center study of 378 patients with EIN. Ultimately, 27% (n = 103) of the patients were diagnosed with endometrial cancer – 95% with stage 1a disease and 5% with stage 1b.

Increasing age, White race, and hypertension were significantly associated with the presence of endometrial cancer. Body mass index, parity, hormone therapy exposure, and baseline CA 125 were not.

The median preoperative endometrial thickness was 14 mm among patients with endometrial cancer and 11 mm in patients without cancer (P = .002).

Overall, 31% of the cancer cases were considered high risk for nodal metastases by Mayo criteria, but an endometrial stripe of 15 mm or higher increased the chance of being considered high risk.

The risk of cancer was 47% among patients with an endometrial stripe of at least 20 mm versus 21% among patients with a measurement below 15 mm.

Only 10 patients underwent lymph node evaluation, 5 with sentinel lymph node dissection and 5 with lymphadenectomy. Six of the 10 patients had endometrial cancer on final pathology, but none had positive lymph nodes.

“Given the low-grade and early-stage disease in this cohort, adherence to a routine sentinel lymph node algorithm in all patients with EIN would result in overtreatment,” Dr. Abt said.

Discussant Nicole Fleming, MD, of the University of Texas MD Anderson Cancer Center, Houston, said she would advocate for more selective use of sentinel lymph node biopsies in EIN as well.

Dr. Fleming said, in general, lymph node biopsy may be reasonable in settings where frozen sections are unreliable and the patient seems to be at high risk of invasive cancer. However, at academic centers with dedicated gynecologic pathologists, given the low risk of invasive cancer and the fact that lymph nodes “are probably not going to provide you a lot of useful therapeutic decision-making tools,” potentially eliminating sentinel lymph node biopsy might make sense, Dr. Fleming said.

Dr. Fleming disclosed relationships with Tesaro, Bristol-Myers Squibb, Pfizer, and GlaxoSmithKline. Dr. Abt reported having no relevant disclosures and did not report any study funding.

[email protected]

Preoperative endometrial thickness is associated with the risk of endometrial cancer in patients with endometrial intraepithelial neoplasia (EIN) and could potentially be used to guide lymph node assessment, according to investigators.

In a retrospective study of 378 patients who had hysterectomies for EIN, those with a preoperative endometrial stripe of 20 mm or greater were two times more likely to have endometrial cancer on final pathology, and those with an endometrial thickness of 15 mm or greater were 1.8 times more likely to have cancer.

“This data suggests that increasing endometrial thickness may be a useful preoperative marker to identify who’s at higher risk of concurrent endometrial cancer. It could also be considered a criterion for selectively using a sentinel lymph node algorithm in patients with a preoperative diagnosis of EIN. However, prospective studies are warranted to further establish this association,” said Devon Abt, MD, of Beth Israel Deaconess Medical Center in Boston.

She presented the data at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11103).
 

Risk of overtreatment

There are no clear consensus guidelines on lymph node assessment for patients with EIN, Dr. Abt noted. She pointed out that roughly 40% of patients with EIN are diagnosed with endometrial cancer. However, it’s usually low-stage, low-grade disease, and only about 10% of patients will have high-risk features that warrant lymph node evaluation.

“Typically, we identify patients with concurrent endometrial cancer based on intraoperative pathology, or frozen section,” Dr. Abt explained. “We then apply the Mayo criteria, which stratifies patients as high or low risk for lymph node metastasis based on pathologic criteria. ... This information helps guide our intraoperative decisions to perform, or not perform, pelvic and para-aortic lymphadenectomy.”

Dr. Abt noted, however, that “lymphadenectomy is not benign” and increases surgical time as well as the risk of complications.

Taking these factors into account, some centers have implemented routine sentinel lymph node algorithms for staging endometrial cancers, Dr. Abt said.

What she and her colleagues wanted to determine is if there is value in this practice. Should sentinel lymph node mapping and biopsy be offered routinely to all patients with a preoperative diagnosis of EIN?
 

Study details

Dr. Abt and colleagues conducted a retrospective, single-center study of 378 patients with EIN. Ultimately, 27% (n = 103) of the patients were diagnosed with endometrial cancer – 95% with stage 1a disease and 5% with stage 1b.

Increasing age, White race, and hypertension were significantly associated with the presence of endometrial cancer. Body mass index, parity, hormone therapy exposure, and baseline CA 125 were not.

The median preoperative endometrial thickness was 14 mm among patients with endometrial cancer and 11 mm in patients without cancer (P = .002).

Overall, 31% of the cancer cases were considered high risk for nodal metastases by Mayo criteria, but an endometrial stripe of 15 mm or higher increased the chance of being considered high risk.

The risk of cancer was 47% among patients with an endometrial stripe of at least 20 mm versus 21% among patients with a measurement below 15 mm.

Only 10 patients underwent lymph node evaluation, 5 with sentinel lymph node dissection and 5 with lymphadenectomy. Six of the 10 patients had endometrial cancer on final pathology, but none had positive lymph nodes.

“Given the low-grade and early-stage disease in this cohort, adherence to a routine sentinel lymph node algorithm in all patients with EIN would result in overtreatment,” Dr. Abt said.

Discussant Nicole Fleming, MD, of the University of Texas MD Anderson Cancer Center, Houston, said she would advocate for more selective use of sentinel lymph node biopsies in EIN as well.

Dr. Fleming said, in general, lymph node biopsy may be reasonable in settings where frozen sections are unreliable and the patient seems to be at high risk of invasive cancer. However, at academic centers with dedicated gynecologic pathologists, given the low risk of invasive cancer and the fact that lymph nodes “are probably not going to provide you a lot of useful therapeutic decision-making tools,” potentially eliminating sentinel lymph node biopsy might make sense, Dr. Fleming said.

Dr. Fleming disclosed relationships with Tesaro, Bristol-Myers Squibb, Pfizer, and GlaxoSmithKline. Dr. Abt reported having no relevant disclosures and did not report any study funding.

[email protected]

A 74-year-old woman presented to the dermatology clinic for follow-up 3 months after the surgical excision of a basal cell carcinoma on her left jawline. During this postop period, the patient developed new-onset hirsutism. She appeared to be in otherwise good health.

Family and personal medical history were unremarkable. Her medication regimen included aspirin 81 mg/d and a daily multivitamin. The patient was postmenopausal and had a body mass index of 28 and a history of acid reflux and osteoarthritis.

Physical examination of the patient’s scalp showed male-pattern alopecia (FIGURE 1A). She also had coarse terminal hairs on her forearms and back, as well as on her chin (FIGURE 1B).

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Dx: Androgen-secreting ovarian tumor

Based on the distribution of terminal hairs and marked change over 3 months, as well as the male-pattern alopecia, a diagnosis of androgen excess was suspected. Laboratory work-up, including thyroid-stimulating hormone, dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone, luteinizing hormone, prolactin, complete blood count, and complete metabolic panel, was within normal limits. Pelvic ultrasound of the ovaries and abdominal computed tomography (CT) of the adrenal glands were also normal.

Further testing showed an elevated testosterone level of 464 ng/dL (reference range: 2-45 ng/dL) and an elevated free testosterone level of 66.8 ng/dL (reference range: 0.2-3.7 ng/dL). These levels pointed to an androgen-secreting ovarian tumor; the androgen excess was likely the cause of her hirsutism.

Hirsutism or hypertrichosis?

Hirsutism, a common disorder affecting up to 8% of women, is defined by excess terminal hairs that appear in a male pattern in women due to production of excess androgens.¹ This should be distinguished from hypertrichosis, which is generalized excessive hair growth not caused by androgen excess.

Hirsutism is more often associated with adrenal or ovarian tumors in postmenopausal patients.

Testosterone and DHEAS—produced in the ovaries and adrenal glands, respectively—contribute to the development of hirsutism.¹ Hirsutism is more often associated with adrenal or ovarian tumors in postmenopausal patients.² Generalized hypertrichosis can be associated with porphyria cutanea tarda, severe anorexia nervosa, and rarely, malignancies; it also can be secondary to certain agents, such as cyclosporin, phenytoin, and minoxidil.

While hirsutism is associated with hyperandrogenemia, its degree correlates poorly with serum levels. Notably, about half of women with hirsutism have been found to have normal levels of circulating androgens.¹ Severe signs of hyperandrogenemia include rapid onset of symptoms, signs of virilization, and a palpable abdominal or pelvic mass.³

Continue to: Is the patient pre- or postmenopausal?

Is the patient pre- or postmenopausal? Polycystic ovary syndrome (PCOS) accounts for up to three-fourths of premenopausal hirsutism.³ The likelihood of hirsutism is actually decreased in postmenopausal women because estrogen levels can drop abruptly after menopause. That said, conditions linked to hirsutism in postmenopausal women include adrenal hyperplasia, thyroid dysfunction, Cushing syndrome, and least frequently, androgen-secreting tumors (seen in this patient). (Hirsutism can also be idiopathic or iatrogenic [medications].)

Methods for detection

Research suggests that when a female patient is given a diagnosis of hirsutism, it’s important to explore possible underlying ovarian and/or adrenal tumors and adult-onset adrenal hyperplasia.¹ The following tests and procedure can be helpful:

Serum testosterone and DHEAS. Levels of total testosterone > 200 ng/dL and/or DHEAS > 700 ng/dL are strongly indicative of androgen-secreting tumors.¹

Imaging—including ultrasound, CT, or magnetic resonance imaging—can be used for evaluation of the adrenal glands and ovaries. However, imaging is often unable to identify these small tumors.⁴

Selective venous catheterization can be useful in the localization and lateralization of an androgen-secreting tumor, although a nondiagnostic result with this technique is not uncommon.⁴

Continue to: Dynamic hormonal testing

Dynamic hormonal testing may assist in determining the pathology of disease but not laterality.² For example, testing for gonadotropin-releasing hormone agonists can be helpful because the constant administration of such agonists can lead to ovarian suppression without affecting adrenal androgen secretion.⁵

Testing with oral dexamethasone may induce adrenal hormonal depression of androgens and subsequent estradiol through aromatase conversion, which can help rule out an ovarian source.⁶ Exogenous administration of follicle-stimulating hormone or luteinizing hormone can further differentiate the source from ovarian theca or granulosa cell production.⁴

Treatment varies

The specific etiology of a patient’s hirsutism dictates the most appropriate treatment. For example, medication-induced hirsutism often requires discontinuation of the offending agent, whereas PCOS would necessitate appropriate nonpharmacologic and pharmacologic interventions.

For our patient, the elevated testosterone and free testosterone levels with normal DHEAS strongly suggested the presence of an androgen-secreting ovarian tumor. These findings led to a referral for bilateral salpingo-oophorectomy. The surgical gross appearance of the patient’s ovaries was unremarkable, but gross dissection and pathology of the ovaries (which were not postoperatively identified to determine laterality) showed one was larger (2.7 × 1.5 × 0.8 cm vs 3.2 × 1.4 × 1.2 cm).

The larger ovary contained an area of brown induration measuring 2.3 × 1.1 × 1.1 cm. This area corresponded to abundant eosinophilic cytoplasm with nuclear, rich, round-cell proliferation, consistent with the diagnosis of a benign ovarian Leydig cell tumor (FIGURE 2). Thus, the bilateral salpingo-oophorectomy was both diagnostic and therapeutic.

Six weeks after the surgery, blood work showed normalization of testosterone and free testosterone levels. The patient’s hirsutism completely resolved over the course of the next several months.

A 74-year-old woman presented to the dermatology clinic for follow-up 3 months after the surgical excision of a basal cell carcinoma on her left jawline. During this postop period, the patient developed new-onset hirsutism. She appeared to be in otherwise good health.

Family and personal medical history were unremarkable. Her medication regimen included aspirin 81 mg/d and a daily multivitamin. The patient was postmenopausal and had a body mass index of 28 and a history of acid reflux and osteoarthritis.

Physical examination of the patient’s scalp showed male-pattern alopecia (FIGURE 1A). She also had coarse terminal hairs on her forearms and back, as well as on her chin (FIGURE 1B).

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Dx: Androgen-secreting ovarian tumor

Based on the distribution of terminal hairs and marked change over 3 months, as well as the male-pattern alopecia, a diagnosis of androgen excess was suspected. Laboratory work-up, including thyroid-stimulating hormone, dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone, luteinizing hormone, prolactin, complete blood count, and complete metabolic panel, was within normal limits. Pelvic ultrasound of the ovaries and abdominal computed tomography (CT) of the adrenal glands were also normal.

Further testing showed an elevated testosterone level of 464 ng/dL (reference range: 2-45 ng/dL) and an elevated free testosterone level of 66.8 ng/dL (reference range: 0.2-3.7 ng/dL). These levels pointed to an androgen-secreting ovarian tumor; the androgen excess was likely the cause of her hirsutism.

Hirsutism or hypertrichosis?

Hirsutism, a common disorder affecting up to 8% of women, is defined by excess terminal hairs that appear in a male pattern in women due to production of excess androgens.¹ This should be distinguished from hypertrichosis, which is generalized excessive hair growth not caused by androgen excess.

Hirsutism is more often associated with adrenal or ovarian tumors in postmenopausal patients.

Testosterone and DHEAS—produced in the ovaries and adrenal glands, respectively—contribute to the development of hirsutism.¹ Hirsutism is more often associated with adrenal or ovarian tumors in postmenopausal patients.² Generalized hypertrichosis can be associated with porphyria cutanea tarda, severe anorexia nervosa, and rarely, malignancies; it also can be secondary to certain agents, such as cyclosporin, phenytoin, and minoxidil.

While hirsutism is associated with hyperandrogenemia, its degree correlates poorly with serum levels. Notably, about half of women with hirsutism have been found to have normal levels of circulating androgens.¹ Severe signs of hyperandrogenemia include rapid onset of symptoms, signs of virilization, and a palpable abdominal or pelvic mass.³

Continue to: Is the patient pre- or postmenopausal?

Is the patient pre- or postmenopausal? Polycystic ovary syndrome (PCOS) accounts for up to three-fourths of premenopausal hirsutism.³ The likelihood of hirsutism is actually decreased in postmenopausal women because estrogen levels can drop abruptly after menopause. That said, conditions linked to hirsutism in postmenopausal women include adrenal hyperplasia, thyroid dysfunction, Cushing syndrome, and least frequently, androgen-secreting tumors (seen in this patient). (Hirsutism can also be idiopathic or iatrogenic [medications].)

Methods for detection

Research suggests that when a female patient is given a diagnosis of hirsutism, it’s important to explore possible underlying ovarian and/or adrenal tumors and adult-onset adrenal hyperplasia.¹ The following tests and procedure can be helpful:

Serum testosterone and DHEAS. Levels of total testosterone > 200 ng/dL and/or DHEAS > 700 ng/dL are strongly indicative of androgen-secreting tumors.¹

Imaging—including ultrasound, CT, or magnetic resonance imaging—can be used for evaluation of the adrenal glands and ovaries. However, imaging is often unable to identify these small tumors.⁴

Selective venous catheterization can be useful in the localization and lateralization of an androgen-secreting tumor, although a nondiagnostic result with this technique is not uncommon.⁴

Continue to: Dynamic hormonal testing

Dynamic hormonal testing may assist in determining the pathology of disease but not laterality.² For example, testing for gonadotropin-releasing hormone agonists can be helpful because the constant administration of such agonists can lead to ovarian suppression without affecting adrenal androgen secretion.⁵

Testing with oral dexamethasone may induce adrenal hormonal depression of androgens and subsequent estradiol through aromatase conversion, which can help rule out an ovarian source.⁶ Exogenous administration of follicle-stimulating hormone or luteinizing hormone can further differentiate the source from ovarian theca or granulosa cell production.⁴

Treatment varies

The specific etiology of a patient’s hirsutism dictates the most appropriate treatment. For example, medication-induced hirsutism often requires discontinuation of the offending agent, whereas PCOS would necessitate appropriate nonpharmacologic and pharmacologic interventions.

For our patient, the elevated testosterone and free testosterone levels with normal DHEAS strongly suggested the presence of an androgen-secreting ovarian tumor. These findings led to a referral for bilateral salpingo-oophorectomy. The surgical gross appearance of the patient’s ovaries was unremarkable, but gross dissection and pathology of the ovaries (which were not postoperatively identified to determine laterality) showed one was larger (2.7 × 1.5 × 0.8 cm vs 3.2 × 1.4 × 1.2 cm).

The larger ovary contained an area of brown induration measuring 2.3 × 1.1 × 1.1 cm. This area corresponded to abundant eosinophilic cytoplasm with nuclear, rich, round-cell proliferation, consistent with the diagnosis of a benign ovarian Leydig cell tumor (FIGURE 2). Thus, the bilateral salpingo-oophorectomy was both diagnostic and therapeutic.

Six weeks after the surgery, blood work showed normalization of testosterone and free testosterone levels. The patient’s hirsutism completely resolved over the course of the next several months.

A 74-year-old woman presented to the dermatology clinic for follow-up 3 months after the surgical excision of a basal cell carcinoma on her left jawline. During this postop period, the patient developed new-onset hirsutism. She appeared to be in otherwise good health.

Family and personal medical history were unremarkable. Her medication regimen included aspirin 81 mg/d and a daily multivitamin. The patient was postmenopausal and had a body mass index of 28 and a history of acid reflux and osteoarthritis.

Physical examination of the patient’s scalp showed male-pattern alopecia (FIGURE 1A). She also had coarse terminal hairs on her forearms and back, as well as on her chin (FIGURE 1B).

WHAT IS YOUR DIAGNOSIS?
HOW WOULD YOU TREAT THIS PATIENT?

Dx: Androgen-secreting ovarian tumor

Based on the distribution of terminal hairs and marked change over 3 months, as well as the male-pattern alopecia, a diagnosis of androgen excess was suspected. Laboratory work-up, including thyroid-stimulating hormone, dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone, luteinizing hormone, prolactin, complete blood count, and complete metabolic panel, was within normal limits. Pelvic ultrasound of the ovaries and abdominal computed tomography (CT) of the adrenal glands were also normal.

Further testing showed an elevated testosterone level of 464 ng/dL (reference range: 2-45 ng/dL) and an elevated free testosterone level of 66.8 ng/dL (reference range: 0.2-3.7 ng/dL). These levels pointed to an androgen-secreting ovarian tumor; the androgen excess was likely the cause of her hirsutism.

Hirsutism or hypertrichosis?

Hirsutism, a common disorder affecting up to 8% of women, is defined by excess terminal hairs that appear in a male pattern in women due to production of excess androgens.¹ This should be distinguished from hypertrichosis, which is generalized excessive hair growth not caused by androgen excess.

Hirsutism is more often associated with adrenal or ovarian tumors in postmenopausal patients.

Testosterone and DHEAS—produced in the ovaries and adrenal glands, respectively—contribute to the development of hirsutism.¹ Hirsutism is more often associated with adrenal or ovarian tumors in postmenopausal patients.² Generalized hypertrichosis can be associated with porphyria cutanea tarda, severe anorexia nervosa, and rarely, malignancies; it also can be secondary to certain agents, such as cyclosporin, phenytoin, and minoxidil.

While hirsutism is associated with hyperandrogenemia, its degree correlates poorly with serum levels. Notably, about half of women with hirsutism have been found to have normal levels of circulating androgens.¹ Severe signs of hyperandrogenemia include rapid onset of symptoms, signs of virilization, and a palpable abdominal or pelvic mass.³

Continue to: Is the patient pre- or postmenopausal?

Is the patient pre- or postmenopausal? Polycystic ovary syndrome (PCOS) accounts for up to three-fourths of premenopausal hirsutism.³ The likelihood of hirsutism is actually decreased in postmenopausal women because estrogen levels can drop abruptly after menopause. That said, conditions linked to hirsutism in postmenopausal women include adrenal hyperplasia, thyroid dysfunction, Cushing syndrome, and least frequently, androgen-secreting tumors (seen in this patient). (Hirsutism can also be idiopathic or iatrogenic [medications].)

Methods for detection

Research suggests that when a female patient is given a diagnosis of hirsutism, it’s important to explore possible underlying ovarian and/or adrenal tumors and adult-onset adrenal hyperplasia.¹ The following tests and procedure can be helpful:

Serum testosterone and DHEAS. Levels of total testosterone > 200 ng/dL and/or DHEAS > 700 ng/dL are strongly indicative of androgen-secreting tumors.¹

Imaging—including ultrasound, CT, or magnetic resonance imaging—can be used for evaluation of the adrenal glands and ovaries. However, imaging is often unable to identify these small tumors.⁴

Selective venous catheterization can be useful in the localization and lateralization of an androgen-secreting tumor, although a nondiagnostic result with this technique is not uncommon.⁴

Continue to: Dynamic hormonal testing

Dynamic hormonal testing may assist in determining the pathology of disease but not laterality.² For example, testing for gonadotropin-releasing hormone agonists can be helpful because the constant administration of such agonists can lead to ovarian suppression without affecting adrenal androgen secretion.⁵

Testing with oral dexamethasone may induce adrenal hormonal depression of androgens and subsequent estradiol through aromatase conversion, which can help rule out an ovarian source.⁶ Exogenous administration of follicle-stimulating hormone or luteinizing hormone can further differentiate the source from ovarian theca or granulosa cell production.⁴

Treatment varies

The specific etiology of a patient’s hirsutism dictates the most appropriate treatment. For example, medication-induced hirsutism often requires discontinuation of the offending agent, whereas PCOS would necessitate appropriate nonpharmacologic and pharmacologic interventions.

For our patient, the elevated testosterone and free testosterone levels with normal DHEAS strongly suggested the presence of an androgen-secreting ovarian tumor. These findings led to a referral for bilateral salpingo-oophorectomy. The surgical gross appearance of the patient’s ovaries was unremarkable, but gross dissection and pathology of the ovaries (which were not postoperatively identified to determine laterality) showed one was larger (2.7 × 1.5 × 0.8 cm vs 3.2 × 1.4 × 1.2 cm).

The larger ovary contained an area of brown induration measuring 2.3 × 1.1 × 1.1 cm. This area corresponded to abundant eosinophilic cytoplasm with nuclear, rich, round-cell proliferation, consistent with the diagnosis of a benign ovarian Leydig cell tumor (FIGURE 2). Thus, the bilateral salpingo-oophorectomy was both diagnostic and therapeutic.

Six weeks after the surgery, blood work showed normalization of testosterone and free testosterone levels. The patient’s hirsutism completely resolved over the course of the next several months.

People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.

Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one  unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.

To find out how physicians can provide more compassionate, effective care for this group, this news organization spoke with K. Ashley Brandt, DO, gender-affirming surgeon and obstetrician/gynecologist in West Reading, Penn. This interview has been edited for length and clarity.

Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?

Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.

The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.

What can clinics and clinicians do to create a safe and welcoming environment?

Dr. Brandt: It starts with educating office staff about terminology and gender identities.

A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.

There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room.  A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.

Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?

Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.

It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.

Do you think that many physicians are educated about the care of underserved populations such as transgender patients?

Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.

However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.

But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.

What should physicians keep in mind when treating patients who identify as transgender?

Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.

Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.

What are your top health concerns for these patients and how do you address them?

Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.

Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.

Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.

Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?

Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.

Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?

Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.

People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.

Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.

Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.

Do you have any strategies on how to make the appointment more successful in addressing those issues?

Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.

If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.

That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.

A version of this article first appeared on Medscape.com.

People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.

Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one  unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.

To find out how physicians can provide more compassionate, effective care for this group, this news organization spoke with K. Ashley Brandt, DO, gender-affirming surgeon and obstetrician/gynecologist in West Reading, Penn. This interview has been edited for length and clarity.

Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?

Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.

The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.

What can clinics and clinicians do to create a safe and welcoming environment?

Dr. Brandt: It starts with educating office staff about terminology and gender identities.

A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.

There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room.  A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.

Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?

Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.

It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.

Do you think that many physicians are educated about the care of underserved populations such as transgender patients?

Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.

However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.

But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.

What should physicians keep in mind when treating patients who identify as transgender?

Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.

Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.

What are your top health concerns for these patients and how do you address them?

Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.

Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.

Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.

Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?

Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.

Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?

Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.

People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.

Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.

Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.

Do you have any strategies on how to make the appointment more successful in addressing those issues?

Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.

If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.

That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.

A version of this article first appeared on Medscape.com.

People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.

Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one  unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.

To find out how physicians can provide more compassionate, effective care for this group, this news organization spoke with K. Ashley Brandt, DO, gender-affirming surgeon and obstetrician/gynecologist in West Reading, Penn. This interview has been edited for length and clarity.

Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?

Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.

The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.

What can clinics and clinicians do to create a safe and welcoming environment?

Dr. Brandt: It starts with educating office staff about terminology and gender identities.

A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.

There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room.  A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.

Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?

Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.

It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.

Do you think that many physicians are educated about the care of underserved populations such as transgender patients?

Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.

However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.

But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.

What should physicians keep in mind when treating patients who identify as transgender?

Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.

Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.

What are your top health concerns for these patients and how do you address them?

Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.

Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.

Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.

Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?

Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.

Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?

Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.

People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.

Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.

Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.

Do you have any strategies on how to make the appointment more successful in addressing those issues?

Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.

If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.

That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.

A version of this article first appeared on Medscape.com.

Incorporation of a nonintensive fitness intervention for women with obesity into a standard fertility treatment program could be cost effective, a new analysis finds.

Financial data for the Canadian Fit-for-Fertility program were presented March 20 at the annual meeting of the Endocrine Society by Matea Belan, PhD, of the division of endocrinology at the University of Sherbrooke (Que.).

Women with obesity and infertility are typically advised to lose 5%-10% of their body weight as first-line fertility treatment, as doing so has been shown to increase rates of ovulation and pregnancy. But most established fertility treatment programs don’t incorporate organized lifestyle modification interventions, Dr. Belan explained during a press briefing.

“Mostly they’re just given general advice, not resources. It’s up to the woman to seek help for lifestyle. Our idea is to give them access to intervention that’s integrated into the setting of a fertility clinic,” she said.

Primary results from the Fit-for-Fertility program, including significant weight loss and a 40% increased live birth rate at 18 months, compared with standard fertility treatment, were presented at ENDO 2019 and reported at the time by this news organization.

In the new analysis, the cost in Canadian dollars per additional newborn achieved with the Fit-for-Fertility program was similar to the willingness-to-pay for in vitro fertilization from a health system perspective.

The final goal, lead investigator Jean-Patrice Baillargeon, MD, said in an interview, “would be to convince stakeholders, and mainly the provincial government, to cover the costs of our lifestyle program. This would not be more costly than funding IVF, but [would provide] more long-term benefits for the whole family and the offspring.”

Chloe A. Zera, MD, said in an interview that she supports the idea in principle, but is concerned that, in the U.S. health care system, women don’t always have access to fertility and obesity treatments to begin with.

“There’s a huge equity issue. People with Medicaid don’t necessarily get coverage for IVF. ... Even many commercially insured people are paying out of pocket, which can be $10,000 to $15,000 for a cycle just for the medications, so the cost to patients on the individual level is huge,” said Dr. Zera, who is associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston.

She added: “I’m prolifestyle modification. I’m also proequity in health care delivery so I would want to make sure that the way it’s delivered incorporates that as a consideration. ... Is that money better spent on primary prevention of obesity and access to basic services and basic reproductive health care for everybody?”
 

Primary results: Improvements in overall and spontaneous pregnancy rates

The study included 130 women with infertility and a body mass index of at least 30 kg/m2 (mean, 40), of whom 65 were randomized to the Fit-for-Fitness program and 65 to standard fertility treatment that did not include a lifestyle intervention, although those women could consult professionals on their own. The women in the lifestyle intervention group had to stop medical fertility treatments for the first 6 months but could use them thereafter while the controls continued to use them throughout.

Based on motivational interviewing, the program focused on womens’ individual likes and dislikes, experiences, and perceived capacities, aiming to improve healthful habits gradually and with “low intensity” so as to maintain them in the long run.

The program combined individual sessions with a nutritionist and kinesiologist every 6 weeks and 12 mandatory group sessions. The women were asked to reduce their total caloric intake by about 500 calories/day but weren’t asked to change their diets. They were also advised to increase physical activity by about 150 minutes/week.

“We want to keep it sustainable in time, so they don’t have a relapse when they become pregnant, and to help the newborn and spouse too. It’s about improving and maintaining habits,” Dr. Belan explained during the briefing.

At 6 months, mean weight changes were –3.4% versus –0.89% for the intervention versus control groups (P = .003).

“What is important for women with obesity and infertility is to improve their lifestyle, both physical activity and nutrition, even if the weight loss is minimal,” noted Dr. Baillargeon, professor of medicine, health sciences research and physiology, also at the University of Sherbrooke.

A total of 46 intervention and 52 control patients finished the 18-month study. Pregnancies occurred in 61% of the intervention group versus 39% of the controls, while spontaneous pregnancies – among those not using medical fertility treatments – occurred in 33.3% versus 12.3% (P = .009).

The primary outcome, live births at 18 months, occurred in 51.0% of the intervention group versus 36.8% of controls, which wasn’t a statistically significant difference, but was “highly clinically significant,” Dr. Belan said.
 

Cost per additional newborn similar to IVF

Costs (in Canadian dollars) considered in the analysis included those related to the management of infertility, obesity, pregnancy, and childbirth. The incremental cost-effectiveness ratios, a standard cost-effectiveness measure, per live birth were $24,393 from a societal perspective, $12,633 for the health system, and $5,980 for the patient.

Because the $12,633 health system cost per additional newborn with the Fit-for-Fertility program is similar to the health system’s willingness-to-pay for IVF of up to $15,000, a lifestyle intervention could be considered cost-efficient compared with the standard of care, Dr. Belan said.

“We think that the Fit-for-Fertility program could be deemed cost effective and could represent an interesting alternative to the usual standard of care for women with obesity seeking fertility treatments,” she commented.

The Canadian Institutes of Health Research is funding a larger randomized, controlled trial of the program at six Canadian centers to validate these results.

Dr. Belan, Dr. Baillargeon, and Dr. Zera reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Incorporation of a nonintensive fitness intervention for women with obesity into a standard fertility treatment program could be cost effective, a new analysis finds.

Financial data for the Canadian Fit-for-Fertility program were presented March 20 at the annual meeting of the Endocrine Society by Matea Belan, PhD, of the division of endocrinology at the University of Sherbrooke (Que.).

Women with obesity and infertility are typically advised to lose 5%-10% of their body weight as first-line fertility treatment, as doing so has been shown to increase rates of ovulation and pregnancy. But most established fertility treatment programs don’t incorporate organized lifestyle modification interventions, Dr. Belan explained during a press briefing.

“Mostly they’re just given general advice, not resources. It’s up to the woman to seek help for lifestyle. Our idea is to give them access to intervention that’s integrated into the setting of a fertility clinic,” she said.

Primary results from the Fit-for-Fertility program, including significant weight loss and a 40% increased live birth rate at 18 months, compared with standard fertility treatment, were presented at ENDO 2019 and reported at the time by this news organization.

In the new analysis, the cost in Canadian dollars per additional newborn achieved with the Fit-for-Fertility program was similar to the willingness-to-pay for in vitro fertilization from a health system perspective.

The final goal, lead investigator Jean-Patrice Baillargeon, MD, said in an interview, “would be to convince stakeholders, and mainly the provincial government, to cover the costs of our lifestyle program. This would not be more costly than funding IVF, but [would provide] more long-term benefits for the whole family and the offspring.”

Chloe A. Zera, MD, said in an interview that she supports the idea in principle, but is concerned that, in the U.S. health care system, women don’t always have access to fertility and obesity treatments to begin with.

“There’s a huge equity issue. People with Medicaid don’t necessarily get coverage for IVF. ... Even many commercially insured people are paying out of pocket, which can be $10,000 to $15,000 for a cycle just for the medications, so the cost to patients on the individual level is huge,” said Dr. Zera, who is associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston.

She added: “I’m prolifestyle modification. I’m also proequity in health care delivery so I would want to make sure that the way it’s delivered incorporates that as a consideration. ... Is that money better spent on primary prevention of obesity and access to basic services and basic reproductive health care for everybody?”
 

Primary results: Improvements in overall and spontaneous pregnancy rates

The study included 130 women with infertility and a body mass index of at least 30 kg/m2 (mean, 40), of whom 65 were randomized to the Fit-for-Fitness program and 65 to standard fertility treatment that did not include a lifestyle intervention, although those women could consult professionals on their own. The women in the lifestyle intervention group had to stop medical fertility treatments for the first 6 months but could use them thereafter while the controls continued to use them throughout.

Based on motivational interviewing, the program focused on womens’ individual likes and dislikes, experiences, and perceived capacities, aiming to improve healthful habits gradually and with “low intensity” so as to maintain them in the long run.

The program combined individual sessions with a nutritionist and kinesiologist every 6 weeks and 12 mandatory group sessions. The women were asked to reduce their total caloric intake by about 500 calories/day but weren’t asked to change their diets. They were also advised to increase physical activity by about 150 minutes/week.

“We want to keep it sustainable in time, so they don’t have a relapse when they become pregnant, and to help the newborn and spouse too. It’s about improving and maintaining habits,” Dr. Belan explained during the briefing.

At 6 months, mean weight changes were –3.4% versus –0.89% for the intervention versus control groups (P = .003).

“What is important for women with obesity and infertility is to improve their lifestyle, both physical activity and nutrition, even if the weight loss is minimal,” noted Dr. Baillargeon, professor of medicine, health sciences research and physiology, also at the University of Sherbrooke.

A total of 46 intervention and 52 control patients finished the 18-month study. Pregnancies occurred in 61% of the intervention group versus 39% of the controls, while spontaneous pregnancies – among those not using medical fertility treatments – occurred in 33.3% versus 12.3% (P = .009).

The primary outcome, live births at 18 months, occurred in 51.0% of the intervention group versus 36.8% of controls, which wasn’t a statistically significant difference, but was “highly clinically significant,” Dr. Belan said.
 

Cost per additional newborn similar to IVF

Costs (in Canadian dollars) considered in the analysis included those related to the management of infertility, obesity, pregnancy, and childbirth. The incremental cost-effectiveness ratios, a standard cost-effectiveness measure, per live birth were $24,393 from a societal perspective, $12,633 for the health system, and $5,980 for the patient.

Because the $12,633 health system cost per additional newborn with the Fit-for-Fertility program is similar to the health system’s willingness-to-pay for IVF of up to $15,000, a lifestyle intervention could be considered cost-efficient compared with the standard of care, Dr. Belan said.

“We think that the Fit-for-Fertility program could be deemed cost effective and could represent an interesting alternative to the usual standard of care for women with obesity seeking fertility treatments,” she commented.

The Canadian Institutes of Health Research is funding a larger randomized, controlled trial of the program at six Canadian centers to validate these results.

Dr. Belan, Dr. Baillargeon, and Dr. Zera reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Incorporation of a nonintensive fitness intervention for women with obesity into a standard fertility treatment program could be cost effective, a new analysis finds.

Financial data for the Canadian Fit-for-Fertility program were presented March 20 at the annual meeting of the Endocrine Society by Matea Belan, PhD, of the division of endocrinology at the University of Sherbrooke (Que.).

Women with obesity and infertility are typically advised to lose 5%-10% of their body weight as first-line fertility treatment, as doing so has been shown to increase rates of ovulation and pregnancy. But most established fertility treatment programs don’t incorporate organized lifestyle modification interventions, Dr. Belan explained during a press briefing.

“Mostly they’re just given general advice, not resources. It’s up to the woman to seek help for lifestyle. Our idea is to give them access to intervention that’s integrated into the setting of a fertility clinic,” she said.

Primary results from the Fit-for-Fertility program, including significant weight loss and a 40% increased live birth rate at 18 months, compared with standard fertility treatment, were presented at ENDO 2019 and reported at the time by this news organization.

In the new analysis, the cost in Canadian dollars per additional newborn achieved with the Fit-for-Fertility program was similar to the willingness-to-pay for in vitro fertilization from a health system perspective.

The final goal, lead investigator Jean-Patrice Baillargeon, MD, said in an interview, “would be to convince stakeholders, and mainly the provincial government, to cover the costs of our lifestyle program. This would not be more costly than funding IVF, but [would provide] more long-term benefits for the whole family and the offspring.”

Chloe A. Zera, MD, said in an interview that she supports the idea in principle, but is concerned that, in the U.S. health care system, women don’t always have access to fertility and obesity treatments to begin with.

“There’s a huge equity issue. People with Medicaid don’t necessarily get coverage for IVF. ... Even many commercially insured people are paying out of pocket, which can be $10,000 to $15,000 for a cycle just for the medications, so the cost to patients on the individual level is huge,” said Dr. Zera, who is associate professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston.

She added: “I’m prolifestyle modification. I’m also proequity in health care delivery so I would want to make sure that the way it’s delivered incorporates that as a consideration. ... Is that money better spent on primary prevention of obesity and access to basic services and basic reproductive health care for everybody?”
 

Primary results: Improvements in overall and spontaneous pregnancy rates

The study included 130 women with infertility and a body mass index of at least 30 kg/m2 (mean, 40), of whom 65 were randomized to the Fit-for-Fitness program and 65 to standard fertility treatment that did not include a lifestyle intervention, although those women could consult professionals on their own. The women in the lifestyle intervention group had to stop medical fertility treatments for the first 6 months but could use them thereafter while the controls continued to use them throughout.

Based on motivational interviewing, the program focused on womens’ individual likes and dislikes, experiences, and perceived capacities, aiming to improve healthful habits gradually and with “low intensity” so as to maintain them in the long run.

The program combined individual sessions with a nutritionist and kinesiologist every 6 weeks and 12 mandatory group sessions. The women were asked to reduce their total caloric intake by about 500 calories/day but weren’t asked to change their diets. They were also advised to increase physical activity by about 150 minutes/week.

“We want to keep it sustainable in time, so they don’t have a relapse when they become pregnant, and to help the newborn and spouse too. It’s about improving and maintaining habits,” Dr. Belan explained during the briefing.

At 6 months, mean weight changes were –3.4% versus –0.89% for the intervention versus control groups (P = .003).

“What is important for women with obesity and infertility is to improve their lifestyle, both physical activity and nutrition, even if the weight loss is minimal,” noted Dr. Baillargeon, professor of medicine, health sciences research and physiology, also at the University of Sherbrooke.

A total of 46 intervention and 52 control patients finished the 18-month study. Pregnancies occurred in 61% of the intervention group versus 39% of the controls, while spontaneous pregnancies – among those not using medical fertility treatments – occurred in 33.3% versus 12.3% (P = .009).

The primary outcome, live births at 18 months, occurred in 51.0% of the intervention group versus 36.8% of controls, which wasn’t a statistically significant difference, but was “highly clinically significant,” Dr. Belan said.
 

Cost per additional newborn similar to IVF

Costs (in Canadian dollars) considered in the analysis included those related to the management of infertility, obesity, pregnancy, and childbirth. The incremental cost-effectiveness ratios, a standard cost-effectiveness measure, per live birth were $24,393 from a societal perspective, $12,633 for the health system, and $5,980 for the patient.

Because the $12,633 health system cost per additional newborn with the Fit-for-Fertility program is similar to the health system’s willingness-to-pay for IVF of up to $15,000, a lifestyle intervention could be considered cost-efficient compared with the standard of care, Dr. Belan said.

“We think that the Fit-for-Fertility program could be deemed cost effective and could represent an interesting alternative to the usual standard of care for women with obesity seeking fertility treatments,” she commented.

The Canadian Institutes of Health Research is funding a larger randomized, controlled trial of the program at six Canadian centers to validate these results.

Dr. Belan, Dr. Baillargeon, and Dr. Zera reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

An investigational vaginal gel significantly reduced urogenital chlamydia and gonorrhea in women at high risk for infection, compared with placebo, opening up new possibilities for an on-demand prevention option. Investigators of a randomized trial reported these findings in the American Journal of Obstetrics and Gynecology.

Rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are on the rise in the United States, despite wide availability of male and female condoms to prevent sexually transmitted infections. This suggests that women need a more discrete method that they can better control. Other vaginal microbicides developed over the last few decades haven’t performed well in protecting against STIs or HIV in clinical trials.

The slightly alkaline nature of human semen has the potential to neutralize vaginal pH after intercourse, creating a more vulnerable environment for STIs. EVO100 is an investigational antimicrobial, bioadhesive vaginal gel that contains L-lactic acid, citric acid, and potassium bitartrate. In preclinical studies, it was highly effective at buffering the alkaline properties of human semen and maintaining vaginal pH levels. Patients generally tolerated it well, aside from some reports of vaginal itching and burning.

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration is warning health care providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between Jan. 1, 2017, and Feb. 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Although it’s early in the investigation, on the basis of available data, the FDA believes the risk for infection is low.

“We are very concerned about the three reported deaths – outside of the United States – associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement released on April 1.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug.

The FDA said the third victim’s death involved a cystoscope that did not pass a leak test. It is possible that the damaged device was a factor in the patient’s becoming infected.

It’s not known to what degree the reported infections or patient comorbidities played a part in the patient deaths. The FDA also hasn’t concluded that any specific manufacturer or brand of these devices is associated with higher risks than others.

The FDA released recommendations for processing and using these devices and emphasized the importance of following manufacturers’ labeling and reprocessing instructions to minimize the risk for infection.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance, and discussing the potential benefits and risks associated with procedures involving reprocessed urologic endoscopes with patients.

The newly reported concerns with urologic endoscopes are similar to problems associated with reprocessed duodenoscopes. In 2018, the FDA warned about higher-than-expected contamination rates for reprocessed duodenoscopes. The FDA has taken action on infections related to the reprocessing of duodenoscopes. In 2015, it required postmarket safety studies and the updating of sampling and culturing protocols. In 2019, the FDA approved single-use duodenoscopes in an effort to curb infections.

A version of this article first appeared on Medscape.com.