A novel DNA-based test may prove useful for identifying which chronic myeloid leukemia patients with undetectable BCR-ABL1 transcripts can safely discontinue tyrosine kinase inhibitor (TKI) therapy, according to Mary Alikian, Ph.D., of Hammersmith Hospital, London, and her colleagues.

The test can quantify very low levels of residual disease in peripheral blood samples from patients with CML in whom BCR-ABL1 transcripts were undetectable using reverse transcription quantitative polymerase chain reaction (RT-qPCR), the researchers reported in a study published online in the Journal of Molecular Diagnostics.

©Jezperklauzen/ThinkStock

Their personalized DNA-based digital PCR method rapidly identifies t(9;22) fusion junctions using targeted next-generation sequencing and generates high-performance DNA-based hydrolysis probe assays that are specific to the unique molecular footprint of each patient’s CML clone. The researchers further enhanced the sensitivity of the DNA-based approach by optimizing the technique for use on a digital PCR (dPCR) platform, which provides absolute molecular quantification without the need for a standard curve. This approach avoids laborious breakpoint mapping and improves sensitivity.

The researchers successfully mapped genomic breakpoints in all samples from 32 patients with early-stage disease. Using DNA-based dPCR, disease was quantified in 46 follow-up samples from 6 of the 32 patients, including 36 samples that were in deep molecular remission.

Digital PCR for BCR-ABL1 DNA detected persistent disease in 81% of the molecular-remission samples, outperforming both RT-dPCR (25%) and DNA-based quantitative PCR (19%), the researchers reported (J Mol Diagn. 2016;18:176e189).

Of CML patients who achieve sustained undetectable BCR-ABL1 transcripts on TKI therapy, about 60% experience the return of detectable disease after stopping TKIs and have to restart treatment. An improved method of identifying patients with the lowest likelihood of relapse would allow safe withdrawal of TKI therapy for the 40% of patients who would remain disease free.

The researchers are currently investigating the impact of residual-disease level as assessed by dPCR at the time of treatment withdrawal on outcome within the UK-based DESTINY clinical trial (Deescalation and Stopping Treatment of Imatinib, Nilotinib or Sprycel in Chronic Myeloid Leukaemia). “If validated in clinical trials of stopping TKI, the technique will permit a more personalized approach to recommendations for dose reduction or drug cessation in individual patients, ensuring that therapy is withdrawn only from patients with the highest likelihood of long-term remission,” they wrote.

Identifying genomic breakpoints as soon as CML is diagnosed would allow for the design and optimization of a patient-specific assay. Patients’ response to therapy would then be monitored via standard RT-qPCR until they have reached molecular response. Thereafter, routine monitoring would be augmented with DNA quantification by dPCR and would benefit from the publication of standardized guidelines, as with RT-qPCR.

In the future, it will therefore be important to explore not only whether the risk of relapse after withdrawal is a feature of the number of residual CML cells but also whether it relates to the degree of transcriptional activity in those cells, the researchers wrote. “We observed that 8% (3 of 36) of the samples were positive by RNA-based but negative by DNA-based methods. Conversely, in samples with detectable BCR-ABL1 DNA, there was heterogeneity in the detectability of transcript by RT-dPCR that appeared to be unrelated to the amount of BCR-ABL1 DNA detected. It should be borne in mind that RT and cDNA synthesis steps remain a potential source of variation affecting cDNA concentration, and therefore these results should be interpreted with caution.”

The researchers had no relevant disclosures. The study was supported by Leading Leukemia Research (LEUKA) charity grant 06/Q0406/47, the National Institute for Health Research Biomedical Research Center Funding Scheme, and the Imperial College High Performance Computing Service.

[email protected]

On Twitter @maryjodales

A novel DNA-based test may prove useful for identifying which chronic myeloid leukemia patients with undetectable BCR-ABL1 transcripts can safely discontinue tyrosine kinase inhibitor (TKI) therapy, according to Mary Alikian, Ph.D., of Hammersmith Hospital, London, and her colleagues.

The test can quantify very low levels of residual disease in peripheral blood samples from patients with CML in whom BCR-ABL1 transcripts were undetectable using reverse transcription quantitative polymerase chain reaction (RT-qPCR), the researchers reported in a study published online in the Journal of Molecular Diagnostics.

©Jezperklauzen/ThinkStock

Their personalized DNA-based digital PCR method rapidly identifies t(9;22) fusion junctions using targeted next-generation sequencing and generates high-performance DNA-based hydrolysis probe assays that are specific to the unique molecular footprint of each patient’s CML clone. The researchers further enhanced the sensitivity of the DNA-based approach by optimizing the technique for use on a digital PCR (dPCR) platform, which provides absolute molecular quantification without the need for a standard curve. This approach avoids laborious breakpoint mapping and improves sensitivity.

The researchers successfully mapped genomic breakpoints in all samples from 32 patients with early-stage disease. Using DNA-based dPCR, disease was quantified in 46 follow-up samples from 6 of the 32 patients, including 36 samples that were in deep molecular remission.

Digital PCR for BCR-ABL1 DNA detected persistent disease in 81% of the molecular-remission samples, outperforming both RT-dPCR (25%) and DNA-based quantitative PCR (19%), the researchers reported (J Mol Diagn. 2016;18:176e189).

Of CML patients who achieve sustained undetectable BCR-ABL1 transcripts on TKI therapy, about 60% experience the return of detectable disease after stopping TKIs and have to restart treatment. An improved method of identifying patients with the lowest likelihood of relapse would allow safe withdrawal of TKI therapy for the 40% of patients who would remain disease free.

The researchers are currently investigating the impact of residual-disease level as assessed by dPCR at the time of treatment withdrawal on outcome within the UK-based DESTINY clinical trial (Deescalation and Stopping Treatment of Imatinib, Nilotinib or Sprycel in Chronic Myeloid Leukaemia). “If validated in clinical trials of stopping TKI, the technique will permit a more personalized approach to recommendations for dose reduction or drug cessation in individual patients, ensuring that therapy is withdrawn only from patients with the highest likelihood of long-term remission,” they wrote.

Identifying genomic breakpoints as soon as CML is diagnosed would allow for the design and optimization of a patient-specific assay. Patients’ response to therapy would then be monitored via standard RT-qPCR until they have reached molecular response. Thereafter, routine monitoring would be augmented with DNA quantification by dPCR and would benefit from the publication of standardized guidelines, as with RT-qPCR.

In the future, it will therefore be important to explore not only whether the risk of relapse after withdrawal is a feature of the number of residual CML cells but also whether it relates to the degree of transcriptional activity in those cells, the researchers wrote. “We observed that 8% (3 of 36) of the samples were positive by RNA-based but negative by DNA-based methods. Conversely, in samples with detectable BCR-ABL1 DNA, there was heterogeneity in the detectability of transcript by RT-dPCR that appeared to be unrelated to the amount of BCR-ABL1 DNA detected. It should be borne in mind that RT and cDNA synthesis steps remain a potential source of variation affecting cDNA concentration, and therefore these results should be interpreted with caution.”

The researchers had no relevant disclosures. The study was supported by Leading Leukemia Research (LEUKA) charity grant 06/Q0406/47, the National Institute for Health Research Biomedical Research Center Funding Scheme, and the Imperial College High Performance Computing Service.

[email protected]

On Twitter @maryjodales

A novel DNA-based test may prove useful for identifying which chronic myeloid leukemia patients with undetectable BCR-ABL1 transcripts can safely discontinue tyrosine kinase inhibitor (TKI) therapy, according to Mary Alikian, Ph.D., of Hammersmith Hospital, London, and her colleagues.

The test can quantify very low levels of residual disease in peripheral blood samples from patients with CML in whom BCR-ABL1 transcripts were undetectable using reverse transcription quantitative polymerase chain reaction (RT-qPCR), the researchers reported in a study published online in the Journal of Molecular Diagnostics.

©Jezperklauzen/ThinkStock

Their personalized DNA-based digital PCR method rapidly identifies t(9;22) fusion junctions using targeted next-generation sequencing and generates high-performance DNA-based hydrolysis probe assays that are specific to the unique molecular footprint of each patient’s CML clone. The researchers further enhanced the sensitivity of the DNA-based approach by optimizing the technique for use on a digital PCR (dPCR) platform, which provides absolute molecular quantification without the need for a standard curve. This approach avoids laborious breakpoint mapping and improves sensitivity.

The researchers successfully mapped genomic breakpoints in all samples from 32 patients with early-stage disease. Using DNA-based dPCR, disease was quantified in 46 follow-up samples from 6 of the 32 patients, including 36 samples that were in deep molecular remission.

Digital PCR for BCR-ABL1 DNA detected persistent disease in 81% of the molecular-remission samples, outperforming both RT-dPCR (25%) and DNA-based quantitative PCR (19%), the researchers reported (J Mol Diagn. 2016;18:176e189).

Of CML patients who achieve sustained undetectable BCR-ABL1 transcripts on TKI therapy, about 60% experience the return of detectable disease after stopping TKIs and have to restart treatment. An improved method of identifying patients with the lowest likelihood of relapse would allow safe withdrawal of TKI therapy for the 40% of patients who would remain disease free.

The researchers are currently investigating the impact of residual-disease level as assessed by dPCR at the time of treatment withdrawal on outcome within the UK-based DESTINY clinical trial (Deescalation and Stopping Treatment of Imatinib, Nilotinib or Sprycel in Chronic Myeloid Leukaemia). “If validated in clinical trials of stopping TKI, the technique will permit a more personalized approach to recommendations for dose reduction or drug cessation in individual patients, ensuring that therapy is withdrawn only from patients with the highest likelihood of long-term remission,” they wrote.

Identifying genomic breakpoints as soon as CML is diagnosed would allow for the design and optimization of a patient-specific assay. Patients’ response to therapy would then be monitored via standard RT-qPCR until they have reached molecular response. Thereafter, routine monitoring would be augmented with DNA quantification by dPCR and would benefit from the publication of standardized guidelines, as with RT-qPCR.

In the future, it will therefore be important to explore not only whether the risk of relapse after withdrawal is a feature of the number of residual CML cells but also whether it relates to the degree of transcriptional activity in those cells, the researchers wrote. “We observed that 8% (3 of 36) of the samples were positive by RNA-based but negative by DNA-based methods. Conversely, in samples with detectable BCR-ABL1 DNA, there was heterogeneity in the detectability of transcript by RT-dPCR that appeared to be unrelated to the amount of BCR-ABL1 DNA detected. It should be borne in mind that RT and cDNA synthesis steps remain a potential source of variation affecting cDNA concentration, and therefore these results should be interpreted with caution.”

The researchers had no relevant disclosures. The study was supported by Leading Leukemia Research (LEUKA) charity grant 06/Q0406/47, the National Institute for Health Research Biomedical Research Center Funding Scheme, and the Imperial College High Performance Computing Service.

[email protected]

On Twitter @maryjodales

Rivaroxaban (Xarelto)

The European Medicines Agency (EMA) has concluded that a defect discovered in a system used to measure international normalized ratios (INRs) in the ROCKET AF study does not change the study’s overall conclusions.

The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) was recalled in December 2014 after it was found to produce falsely low test results.

A recent investigation by The BMJ suggested this defect may have impacted the results of ROCKET AF, in which researchers compared warfarin to rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (NVAF).

However, the EMA said further analyses of the study suggest the issue with the INRatio system did not affect the overall safety or benefit-risk balance of rivaroxaban. So rivaroxaban can continue to be used as before, in line with the current prescribing information.

The ROCKET AF study was the main clinical trial underpinning the use of rivaroxaban in patients with NVAF.

The results suggested rivaroxaban was noninferior to warfarin for preventing stroke or systemic embolism in these patients. And there was no significant difference between the treatment arms with regard to major or nonmajor clinically relevant bleeding.

The INRatio system was used to measure INRs in study subjects taking warfarin. Because of the defect, there were concerns that the system could have provided lower INR values in some patients in the warfarin group.

The lower values could, in turn, have led investigators to give too high a dose in the warfarin group, increasing their risk of bleeding and therefore giving a false impression of the comparative safety of rivaroxaban.

So the EMA’s Committee for Medicinal Products for Human Use (CHMP) assessed further analyses of the ROCKET AF study data, taking into account the defect of the INRatio system.

The CHMP concluded that any incorrect measurements obtained with the defective system would have had a marginal effect on the study results, and the safety of rivaroxaban remains unchanged.

In addition, the CHMP said data from other large studies confirmed the comparative safety of rivaroxaban and showed similar rates of bleeding in their warfarin groups.

The CHMP therefore concluded that the benefit-risk balance of rivaroxaban in patients with NVAF remains unchanged.

The CHMP’s assessment report, which includes detailed information on the analyses performed, will be published on the EMA’s website soon.

The EMA started investigating this issue as soon as it was informed of the defect of the INRatio system by the marketing authorization holder of rivaroxaban, Bayer Pharma AG, in September 2015.

Bayer said that, although the INRatio system was recalled in December 2014, the company and its development partner, Janssen, did not become aware of the defect until September 2015.

Rivaroxaban (Xarelto)

The European Medicines Agency (EMA) has concluded that a defect discovered in a system used to measure international normalized ratios (INRs) in the ROCKET AF study does not change the study’s overall conclusions.

The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) was recalled in December 2014 after it was found to produce falsely low test results.

A recent investigation by The BMJ suggested this defect may have impacted the results of ROCKET AF, in which researchers compared warfarin to rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (NVAF).

However, the EMA said further analyses of the study suggest the issue with the INRatio system did not affect the overall safety or benefit-risk balance of rivaroxaban. So rivaroxaban can continue to be used as before, in line with the current prescribing information.

The ROCKET AF study was the main clinical trial underpinning the use of rivaroxaban in patients with NVAF.

The results suggested rivaroxaban was noninferior to warfarin for preventing stroke or systemic embolism in these patients. And there was no significant difference between the treatment arms with regard to major or nonmajor clinically relevant bleeding.

The INRatio system was used to measure INRs in study subjects taking warfarin. Because of the defect, there were concerns that the system could have provided lower INR values in some patients in the warfarin group.

The lower values could, in turn, have led investigators to give too high a dose in the warfarin group, increasing their risk of bleeding and therefore giving a false impression of the comparative safety of rivaroxaban.

So the EMA’s Committee for Medicinal Products for Human Use (CHMP) assessed further analyses of the ROCKET AF study data, taking into account the defect of the INRatio system.

The CHMP concluded that any incorrect measurements obtained with the defective system would have had a marginal effect on the study results, and the safety of rivaroxaban remains unchanged.

In addition, the CHMP said data from other large studies confirmed the comparative safety of rivaroxaban and showed similar rates of bleeding in their warfarin groups.

The CHMP therefore concluded that the benefit-risk balance of rivaroxaban in patients with NVAF remains unchanged.

The CHMP’s assessment report, which includes detailed information on the analyses performed, will be published on the EMA’s website soon.

The EMA started investigating this issue as soon as it was informed of the defect of the INRatio system by the marketing authorization holder of rivaroxaban, Bayer Pharma AG, in September 2015.

Bayer said that, although the INRatio system was recalled in December 2014, the company and its development partner, Janssen, did not become aware of the defect until September 2015.

Rivaroxaban (Xarelto)

The European Medicines Agency (EMA) has concluded that a defect discovered in a system used to measure international normalized ratios (INRs) in the ROCKET AF study does not change the study’s overall conclusions.

The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) was recalled in December 2014 after it was found to produce falsely low test results.

A recent investigation by The BMJ suggested this defect may have impacted the results of ROCKET AF, in which researchers compared warfarin to rivaroxaban (Xarelto) in patients with non-valvular atrial fibrillation (NVAF).

However, the EMA said further analyses of the study suggest the issue with the INRatio system did not affect the overall safety or benefit-risk balance of rivaroxaban. So rivaroxaban can continue to be used as before, in line with the current prescribing information.

The ROCKET AF study was the main clinical trial underpinning the use of rivaroxaban in patients with NVAF.

The results suggested rivaroxaban was noninferior to warfarin for preventing stroke or systemic embolism in these patients. And there was no significant difference between the treatment arms with regard to major or nonmajor clinically relevant bleeding.

The INRatio system was used to measure INRs in study subjects taking warfarin. Because of the defect, there were concerns that the system could have provided lower INR values in some patients in the warfarin group.

The lower values could, in turn, have led investigators to give too high a dose in the warfarin group, increasing their risk of bleeding and therefore giving a false impression of the comparative safety of rivaroxaban.

So the EMA’s Committee for Medicinal Products for Human Use (CHMP) assessed further analyses of the ROCKET AF study data, taking into account the defect of the INRatio system.

The CHMP concluded that any incorrect measurements obtained with the defective system would have had a marginal effect on the study results, and the safety of rivaroxaban remains unchanged.

In addition, the CHMP said data from other large studies confirmed the comparative safety of rivaroxaban and showed similar rates of bleeding in their warfarin groups.

The CHMP therefore concluded that the benefit-risk balance of rivaroxaban in patients with NVAF remains unchanged.

The CHMP’s assessment report, which includes detailed information on the analyses performed, will be published on the EMA’s website soon.

The EMA started investigating this issue as soon as it was informed of the defect of the INRatio system by the marketing authorization holder of rivaroxaban, Bayer Pharma AG, in September 2015.

Bayer said that, although the INRatio system was recalled in December 2014, the company and its development partner, Janssen, did not become aware of the defect until September 2015.

I have had a long and circuitous relationship with the radius. When I was 9 years old, I slipped on the wet grass of our front yard in an attempt to make a highlight-reel baseball catch and landed awkwardly on my left arm. After I continued to complain for a day and a half, my mother took me to see our pediatrician, Dr. Blum. After feeling up and down my forearm and asking me to squeeze his fingers, he pronounced me well.

A week and a half later, when I was still favoring what is my dominant arm, we returned to Dr. Blum. Apparently still unimpressed with my physical exam, he begrudgingly ordered an x-ray. Hurrah! I had a fracture! But then he announced that we would treat it with a splint and an ace wrap. Come on! Everyone knows that if you break a bone you get a cast. From then on he was Dr. Bum to me.

For the next 2 weeks, I was forbidden to play sports, meanwhile losing serious credibility points with my peers who suspected that I was a wimp and had fabricated the whole story. And of course, does anyone go around asking their friends to sign his ace wrap ... really? It took me years of overcompensation to regain even a hint of preteen machismo.

During my last year of medical school, I leapt at the opportunity to take an elective in pediatric orthopedics. It was great! With coaching from the residents, I learned when to suspect a buckle fracture of the radius, identify it on x-ray, and best of all, how to apply a cast.

When I finally entered practice here in Brunswick, we were seriously short of specialists, including orthopedists. When it was discovered that I knew how to apply a forearm cast, the orthopedists encouraged me to treat my own patients with simple forearm fractures. They were more than busy enough with really exciting stuff.

As an artist at heart, the chance to mold in plaster and plastic was a special treat. I took great pride in my creations, and making a beautiful crafted cast was sometimes the high point of my day. No splints or wimpy ace wraps for my patients!

Parents loved the one-stop shopping. History, exam, x-ray, casting, and out the door in less than an hour. Because I was the only primary care physician in town who was casting fractures, I occasionally had to remind the emergency room physicians to send me my patients with buckle fractures instead of knee-jerking a referral to an orthopedist.

But then about 10 years ago, some party-pooping orthopedists from who-knows-where looked at a very large series of pediatric patients with buckle fractures of the radius and discovered that those patients treated with splints had at least as good results as those who had been casted. And ... the patients and parents preferred the splints. I had to admit that maybe Dr. Blum wasn’t such a bum after all. Sadly, I had to respond to the evidence by giving up my hobby except when a child’s temperament or past history of injury suggested that he or she might benefit from the extra protection a cast could afford.

A recent study from Toronto published in Pediatrics, “Primary Care Physician Follow-up of Distal Radius Buckle Fractures,” by Koelink et al., makes me wonder whether a splint and ace wrap may even be overtreatment (Pediatrics. 2016 Jan;137[1]:11-9. doi: 10.1542/peds.2015-2262). In this review of 200 pediatric patients with distal radius buckle fractures, the investigators found that regardless of whether the primary care physician discussed how long to use the splint or when to return to activity, more than two-thirds of the patients wore their splints less than 3 weeks. Despite what the authors considered suboptimal primary care physician guidance, 99% of the patients returned to usual activities within 4 weeks.

My mother and Dr. Blum were on the right track from the beginning. They just needed to ignore my complaints a few days longer.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

I have had a long and circuitous relationship with the radius. When I was 9 years old, I slipped on the wet grass of our front yard in an attempt to make a highlight-reel baseball catch and landed awkwardly on my left arm. After I continued to complain for a day and a half, my mother took me to see our pediatrician, Dr. Blum. After feeling up and down my forearm and asking me to squeeze his fingers, he pronounced me well.

A week and a half later, when I was still favoring what is my dominant arm, we returned to Dr. Blum. Apparently still unimpressed with my physical exam, he begrudgingly ordered an x-ray. Hurrah! I had a fracture! But then he announced that we would treat it with a splint and an ace wrap. Come on! Everyone knows that if you break a bone you get a cast. From then on he was Dr. Bum to me.

For the next 2 weeks, I was forbidden to play sports, meanwhile losing serious credibility points with my peers who suspected that I was a wimp and had fabricated the whole story. And of course, does anyone go around asking their friends to sign his ace wrap ... really? It took me years of overcompensation to regain even a hint of preteen machismo.

During my last year of medical school, I leapt at the opportunity to take an elective in pediatric orthopedics. It was great! With coaching from the residents, I learned when to suspect a buckle fracture of the radius, identify it on x-ray, and best of all, how to apply a cast.

When I finally entered practice here in Brunswick, we were seriously short of specialists, including orthopedists. When it was discovered that I knew how to apply a forearm cast, the orthopedists encouraged me to treat my own patients with simple forearm fractures. They were more than busy enough with really exciting stuff.

As an artist at heart, the chance to mold in plaster and plastic was a special treat. I took great pride in my creations, and making a beautiful crafted cast was sometimes the high point of my day. No splints or wimpy ace wraps for my patients!

Parents loved the one-stop shopping. History, exam, x-ray, casting, and out the door in less than an hour. Because I was the only primary care physician in town who was casting fractures, I occasionally had to remind the emergency room physicians to send me my patients with buckle fractures instead of knee-jerking a referral to an orthopedist.

But then about 10 years ago, some party-pooping orthopedists from who-knows-where looked at a very large series of pediatric patients with buckle fractures of the radius and discovered that those patients treated with splints had at least as good results as those who had been casted. And ... the patients and parents preferred the splints. I had to admit that maybe Dr. Blum wasn’t such a bum after all. Sadly, I had to respond to the evidence by giving up my hobby except when a child’s temperament or past history of injury suggested that he or she might benefit from the extra protection a cast could afford.

A recent study from Toronto published in Pediatrics, “Primary Care Physician Follow-up of Distal Radius Buckle Fractures,” by Koelink et al., makes me wonder whether a splint and ace wrap may even be overtreatment (Pediatrics. 2016 Jan;137[1]:11-9. doi: 10.1542/peds.2015-2262). In this review of 200 pediatric patients with distal radius buckle fractures, the investigators found that regardless of whether the primary care physician discussed how long to use the splint or when to return to activity, more than two-thirds of the patients wore their splints less than 3 weeks. Despite what the authors considered suboptimal primary care physician guidance, 99% of the patients returned to usual activities within 4 weeks.

My mother and Dr. Blum were on the right track from the beginning. They just needed to ignore my complaints a few days longer.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

I have had a long and circuitous relationship with the radius. When I was 9 years old, I slipped on the wet grass of our front yard in an attempt to make a highlight-reel baseball catch and landed awkwardly on my left arm. After I continued to complain for a day and a half, my mother took me to see our pediatrician, Dr. Blum. After feeling up and down my forearm and asking me to squeeze his fingers, he pronounced me well.

A week and a half later, when I was still favoring what is my dominant arm, we returned to Dr. Blum. Apparently still unimpressed with my physical exam, he begrudgingly ordered an x-ray. Hurrah! I had a fracture! But then he announced that we would treat it with a splint and an ace wrap. Come on! Everyone knows that if you break a bone you get a cast. From then on he was Dr. Bum to me.

For the next 2 weeks, I was forbidden to play sports, meanwhile losing serious credibility points with my peers who suspected that I was a wimp and had fabricated the whole story. And of course, does anyone go around asking their friends to sign his ace wrap ... really? It took me years of overcompensation to regain even a hint of preteen machismo.

During my last year of medical school, I leapt at the opportunity to take an elective in pediatric orthopedics. It was great! With coaching from the residents, I learned when to suspect a buckle fracture of the radius, identify it on x-ray, and best of all, how to apply a cast.

When I finally entered practice here in Brunswick, we were seriously short of specialists, including orthopedists. When it was discovered that I knew how to apply a forearm cast, the orthopedists encouraged me to treat my own patients with simple forearm fractures. They were more than busy enough with really exciting stuff.

As an artist at heart, the chance to mold in plaster and plastic was a special treat. I took great pride in my creations, and making a beautiful crafted cast was sometimes the high point of my day. No splints or wimpy ace wraps for my patients!

Parents loved the one-stop shopping. History, exam, x-ray, casting, and out the door in less than an hour. Because I was the only primary care physician in town who was casting fractures, I occasionally had to remind the emergency room physicians to send me my patients with buckle fractures instead of knee-jerking a referral to an orthopedist.

But then about 10 years ago, some party-pooping orthopedists from who-knows-where looked at a very large series of pediatric patients with buckle fractures of the radius and discovered that those patients treated with splints had at least as good results as those who had been casted. And ... the patients and parents preferred the splints. I had to admit that maybe Dr. Blum wasn’t such a bum after all. Sadly, I had to respond to the evidence by giving up my hobby except when a child’s temperament or past history of injury suggested that he or she might benefit from the extra protection a cast could afford.

A recent study from Toronto published in Pediatrics, “Primary Care Physician Follow-up of Distal Radius Buckle Fractures,” by Koelink et al., makes me wonder whether a splint and ace wrap may even be overtreatment (Pediatrics. 2016 Jan;137[1]:11-9. doi: 10.1542/peds.2015-2262). In this review of 200 pediatric patients with distal radius buckle fractures, the investigators found that regardless of whether the primary care physician discussed how long to use the splint or when to return to activity, more than two-thirds of the patients wore their splints less than 3 weeks. Despite what the authors considered suboptimal primary care physician guidance, 99% of the patients returned to usual activities within 4 weeks.

My mother and Dr. Blum were on the right track from the beginning. They just needed to ignore my complaints a few days longer.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

Overall influenza-like illness (ILI) activity underwent a small increase in the United States during week 16 of the 2015-2016 flu season, but Puerto Rico took a significant turn for the worse as activity there rose to the highest possible level, the Centers for Disease Control and Prevention reported Feb. 5.

Puerto Rico, which had been at level 8 on the CDC’s 1-10 scale of flu activity for the previous 3 weeks, jumped up to level 10 for the week ending Jan. 30, 2016. Meanwhile, the main measure for national flu activity, the proportion of outpatient visits for ILI, was 2.2% for the second week in a row, just above the national baseline of 2.1%, the CDC said.

The state with the highest level of flu activity (level 7) for the week was Connecticut, with Arkansas the only other state in the “moderate” range at level 6. States in the “low” range were Florida, Hawaii, Illinois, Maryland, Nevada, New Jersey, and Pennsylvania at level 4 and Georgia, Idaho, Louisiana, Massachusetts, Mississippi, New Mexico, and Virginia at level 3. All told, there were 22 states with activity above level 1, according to data from the CDC’s Outpatient Influenza-like Illness Surveillance Network.

There were two influenza-associated pediatric deaths reported during week 16, although one death actually occurred during the week ending Jan. 16. There have been nine flu-associated pediatric deaths reported so far during the 2015-2016 season.

The hospitalization rate for the season so far is 2.6/100,000 population, up from 2.1/100,000 last week. Adults aged 65 years and older had the highest rate at 8.5/100,000, with children aged 0-4 years next at 3.8/100,000.

[email protected]

Overall influenza-like illness (ILI) activity underwent a small increase in the United States during week 16 of the 2015-2016 flu season, but Puerto Rico took a significant turn for the worse as activity there rose to the highest possible level, the Centers for Disease Control and Prevention reported Feb. 5.

Puerto Rico, which had been at level 8 on the CDC’s 1-10 scale of flu activity for the previous 3 weeks, jumped up to level 10 for the week ending Jan. 30, 2016. Meanwhile, the main measure for national flu activity, the proportion of outpatient visits for ILI, was 2.2% for the second week in a row, just above the national baseline of 2.1%, the CDC said.

The state with the highest level of flu activity (level 7) for the week was Connecticut, with Arkansas the only other state in the “moderate” range at level 6. States in the “low” range were Florida, Hawaii, Illinois, Maryland, Nevada, New Jersey, and Pennsylvania at level 4 and Georgia, Idaho, Louisiana, Massachusetts, Mississippi, New Mexico, and Virginia at level 3. All told, there were 22 states with activity above level 1, according to data from the CDC’s Outpatient Influenza-like Illness Surveillance Network.

There were two influenza-associated pediatric deaths reported during week 16, although one death actually occurred during the week ending Jan. 16. There have been nine flu-associated pediatric deaths reported so far during the 2015-2016 season.

The hospitalization rate for the season so far is 2.6/100,000 population, up from 2.1/100,000 last week. Adults aged 65 years and older had the highest rate at 8.5/100,000, with children aged 0-4 years next at 3.8/100,000.

[email protected]

Overall influenza-like illness (ILI) activity underwent a small increase in the United States during week 16 of the 2015-2016 flu season, but Puerto Rico took a significant turn for the worse as activity there rose to the highest possible level, the Centers for Disease Control and Prevention reported Feb. 5.

Puerto Rico, which had been at level 8 on the CDC’s 1-10 scale of flu activity for the previous 3 weeks, jumped up to level 10 for the week ending Jan. 30, 2016. Meanwhile, the main measure for national flu activity, the proportion of outpatient visits for ILI, was 2.2% for the second week in a row, just above the national baseline of 2.1%, the CDC said.

The state with the highest level of flu activity (level 7) for the week was Connecticut, with Arkansas the only other state in the “moderate” range at level 6. States in the “low” range were Florida, Hawaii, Illinois, Maryland, Nevada, New Jersey, and Pennsylvania at level 4 and Georgia, Idaho, Louisiana, Massachusetts, Mississippi, New Mexico, and Virginia at level 3. All told, there were 22 states with activity above level 1, according to data from the CDC’s Outpatient Influenza-like Illness Surveillance Network.

There were two influenza-associated pediatric deaths reported during week 16, although one death actually occurred during the week ending Jan. 16. There have been nine flu-associated pediatric deaths reported so far during the 2015-2016 season.

The hospitalization rate for the season so far is 2.6/100,000 population, up from 2.1/100,000 last week. Adults aged 65 years and older had the highest rate at 8.5/100,000, with children aged 0-4 years next at 3.8/100,000.

[email protected]

A wearable pulsed electromagnetic fields device reduced pain intensity and improved physical functioning in patients with painful knee osteoarthritis (OA) in a double-blind, randomized trial.

The commercially available device (ActiPatch, Bioelectronics Corp.) did not improve patients’ mental health, but significantly reduced patients’ intake of NSAIDs and analgesics, compared with placebo.

“Although NSAIDs remain the gold standard for the treatment of pain in OA, there is increasing need to find conservative and alternative approaches, in order to avoid the toxicity associated with the chronic use of the analgesics, mostly in the elderly population,” wrote Dr. Gian Luca Bagnato of the University of Messina (Italy) and his colleagues (Rheumatology [Oxford]. 2015 Dec 24. doi: 10.1093/rheumatology/kev426).

courtesy BioElectronics Corporation

Pulsed electromagnetic fields (PEMF) therapy has been shown to reduce chondrocyte apoptosis and MMP-13 expression of knee cartilage and favorably affect cartilage homeostasis in animal models, but data regarding osteoarthritis (OA) pain and function in humans are mixed.

A recent systematic review found no effect in all 14 trials analyzed, but when only high-quality randomized clinical trials were included, PEMF provided significantly better pain relief at 4 and 8 weeks and better function at 8 weeks than did placebo (Rheumatology [Oxford]. 2013;52[5]:815-24).

Not only has the quality of trials varied, so has the PEMF pulse frequency and duration used in trials, “further limiting the possibility of comparing efficacy and safety,” Dr. Bagnato and associates observed.

The current study evenly randomized 60 patients with radiologic evidence of knee OA and persistent pain to wear the PEMF or a placebo device for a minimum of 12 hours, mainly at night, with the device kept in place with a wrap. The active device emits a form of non-ionizing electromagnetic radiation at a frequency of 27.12 MHz, a pulse rate of 1,000 Hz, and a burst width of 100 microsec.

Persistent pain was defined as a minimal mean score of 40 mm for global pain on the VAS (visual analog scale) and daily pain during the month prior to enrollment despite maximal tolerated doses of conventional medical therapy, including acetaminophen and/or an NSAID. The patients’ mean age was 67.7 years and mean OA duration 12 years.

The primary efficacy endpoint was reduction in pain intensity at 1 month on the VAS and WOMAC (Western Ontario and McMaster Universities Arthritis Index). The mean WOMAC total score at baseline was 132.9.

At 1 month, VAS pain scores were reduced 25.5% with the PEMF device and 3.6% with the placebo device. The standardized treatment effect size induced by PEMF therapy was –0.73 (95% confidence interval, –1.24 to –0.19), the investigators reported.

WOMAC pain subscale and total scores fell 23.4% and 18.4% with the PEMF device versus a 2.3% reduction for both scores with the placebo device. The standardized effect size was –0.61 for WOMAC pain (95% CI, –1.12 to –0.09) and –0.34 for WOMAC total score (95% CI, –0.85 to 0.17).

At 1 month, the mean Short Form-36 physical health score was significantly better in the PEMF group than in the placebo group (55.8 vs. 53.1; P = .024), while SF-36 mental health scores were nearly identical (43.8 vs. 43.6; P = .6).

Patients were allowed per protocol to take prescribed analgesic therapy as needed, but eight patients from the PEMF group stopped these medications, while one patient from the placebo group stopped medication and three started a new therapy for chronic pain. No adverse events were reported during the study.

“Given that our data are limited to a low number of participants and the long-term efficacy of the wearable device is unknown, the generalizability of the results needs to be confirmed in a larger clinical trial with a longer duration of treatment,” Dr. Bagnato and his coauthors concluded. “However, the use of a wearable PEMF therapy in knee OA can be considered as an alternative safe and effective therapy in knee OA, providing the possibility for home-based management of pain, compared with previous studies.”

[email protected]

A wearable pulsed electromagnetic fields device reduced pain intensity and improved physical functioning in patients with painful knee osteoarthritis (OA) in a double-blind, randomized trial.

The commercially available device (ActiPatch, Bioelectronics Corp.) did not improve patients’ mental health, but significantly reduced patients’ intake of NSAIDs and analgesics, compared with placebo.

“Although NSAIDs remain the gold standard for the treatment of pain in OA, there is increasing need to find conservative and alternative approaches, in order to avoid the toxicity associated with the chronic use of the analgesics, mostly in the elderly population,” wrote Dr. Gian Luca Bagnato of the University of Messina (Italy) and his colleagues (Rheumatology [Oxford]. 2015 Dec 24. doi: 10.1093/rheumatology/kev426).

courtesy BioElectronics Corporation

Pulsed electromagnetic fields (PEMF) therapy has been shown to reduce chondrocyte apoptosis and MMP-13 expression of knee cartilage and favorably affect cartilage homeostasis in animal models, but data regarding osteoarthritis (OA) pain and function in humans are mixed.

A recent systematic review found no effect in all 14 trials analyzed, but when only high-quality randomized clinical trials were included, PEMF provided significantly better pain relief at 4 and 8 weeks and better function at 8 weeks than did placebo (Rheumatology [Oxford]. 2013;52[5]:815-24).

Not only has the quality of trials varied, so has the PEMF pulse frequency and duration used in trials, “further limiting the possibility of comparing efficacy and safety,” Dr. Bagnato and associates observed.

The current study evenly randomized 60 patients with radiologic evidence of knee OA and persistent pain to wear the PEMF or a placebo device for a minimum of 12 hours, mainly at night, with the device kept in place with a wrap. The active device emits a form of non-ionizing electromagnetic radiation at a frequency of 27.12 MHz, a pulse rate of 1,000 Hz, and a burst width of 100 microsec.

Persistent pain was defined as a minimal mean score of 40 mm for global pain on the VAS (visual analog scale) and daily pain during the month prior to enrollment despite maximal tolerated doses of conventional medical therapy, including acetaminophen and/or an NSAID. The patients’ mean age was 67.7 years and mean OA duration 12 years.

The primary efficacy endpoint was reduction in pain intensity at 1 month on the VAS and WOMAC (Western Ontario and McMaster Universities Arthritis Index). The mean WOMAC total score at baseline was 132.9.

At 1 month, VAS pain scores were reduced 25.5% with the PEMF device and 3.6% with the placebo device. The standardized treatment effect size induced by PEMF therapy was –0.73 (95% confidence interval, –1.24 to –0.19), the investigators reported.

WOMAC pain subscale and total scores fell 23.4% and 18.4% with the PEMF device versus a 2.3% reduction for both scores with the placebo device. The standardized effect size was –0.61 for WOMAC pain (95% CI, –1.12 to –0.09) and –0.34 for WOMAC total score (95% CI, –0.85 to 0.17).

At 1 month, the mean Short Form-36 physical health score was significantly better in the PEMF group than in the placebo group (55.8 vs. 53.1; P = .024), while SF-36 mental health scores were nearly identical (43.8 vs. 43.6; P = .6).

Patients were allowed per protocol to take prescribed analgesic therapy as needed, but eight patients from the PEMF group stopped these medications, while one patient from the placebo group stopped medication and three started a new therapy for chronic pain. No adverse events were reported during the study.

“Given that our data are limited to a low number of participants and the long-term efficacy of the wearable device is unknown, the generalizability of the results needs to be confirmed in a larger clinical trial with a longer duration of treatment,” Dr. Bagnato and his coauthors concluded. “However, the use of a wearable PEMF therapy in knee OA can be considered as an alternative safe and effective therapy in knee OA, providing the possibility for home-based management of pain, compared with previous studies.”

[email protected]

A wearable pulsed electromagnetic fields device reduced pain intensity and improved physical functioning in patients with painful knee osteoarthritis (OA) in a double-blind, randomized trial.

The commercially available device (ActiPatch, Bioelectronics Corp.) did not improve patients’ mental health, but significantly reduced patients’ intake of NSAIDs and analgesics, compared with placebo.

“Although NSAIDs remain the gold standard for the treatment of pain in OA, there is increasing need to find conservative and alternative approaches, in order to avoid the toxicity associated with the chronic use of the analgesics, mostly in the elderly population,” wrote Dr. Gian Luca Bagnato of the University of Messina (Italy) and his colleagues (Rheumatology [Oxford]. 2015 Dec 24. doi: 10.1093/rheumatology/kev426).

courtesy BioElectronics Corporation

Pulsed electromagnetic fields (PEMF) therapy has been shown to reduce chondrocyte apoptosis and MMP-13 expression of knee cartilage and favorably affect cartilage homeostasis in animal models, but data regarding osteoarthritis (OA) pain and function in humans are mixed.

A recent systematic review found no effect in all 14 trials analyzed, but when only high-quality randomized clinical trials were included, PEMF provided significantly better pain relief at 4 and 8 weeks and better function at 8 weeks than did placebo (Rheumatology [Oxford]. 2013;52[5]:815-24).

Not only has the quality of trials varied, so has the PEMF pulse frequency and duration used in trials, “further limiting the possibility of comparing efficacy and safety,” Dr. Bagnato and associates observed.

The current study evenly randomized 60 patients with radiologic evidence of knee OA and persistent pain to wear the PEMF or a placebo device for a minimum of 12 hours, mainly at night, with the device kept in place with a wrap. The active device emits a form of non-ionizing electromagnetic radiation at a frequency of 27.12 MHz, a pulse rate of 1,000 Hz, and a burst width of 100 microsec.

Persistent pain was defined as a minimal mean score of 40 mm for global pain on the VAS (visual analog scale) and daily pain during the month prior to enrollment despite maximal tolerated doses of conventional medical therapy, including acetaminophen and/or an NSAID. The patients’ mean age was 67.7 years and mean OA duration 12 years.

The primary efficacy endpoint was reduction in pain intensity at 1 month on the VAS and WOMAC (Western Ontario and McMaster Universities Arthritis Index). The mean WOMAC total score at baseline was 132.9.

At 1 month, VAS pain scores were reduced 25.5% with the PEMF device and 3.6% with the placebo device. The standardized treatment effect size induced by PEMF therapy was –0.73 (95% confidence interval, –1.24 to –0.19), the investigators reported.

WOMAC pain subscale and total scores fell 23.4% and 18.4% with the PEMF device versus a 2.3% reduction for both scores with the placebo device. The standardized effect size was –0.61 for WOMAC pain (95% CI, –1.12 to –0.09) and –0.34 for WOMAC total score (95% CI, –0.85 to 0.17).

At 1 month, the mean Short Form-36 physical health score was significantly better in the PEMF group than in the placebo group (55.8 vs. 53.1; P = .024), while SF-36 mental health scores were nearly identical (43.8 vs. 43.6; P = .6).

Patients were allowed per protocol to take prescribed analgesic therapy as needed, but eight patients from the PEMF group stopped these medications, while one patient from the placebo group stopped medication and three started a new therapy for chronic pain. No adverse events were reported during the study.

“Given that our data are limited to a low number of participants and the long-term efficacy of the wearable device is unknown, the generalizability of the results needs to be confirmed in a larger clinical trial with a longer duration of treatment,” Dr. Bagnato and his coauthors concluded. “However, the use of a wearable PEMF therapy in knee OA can be considered as an alternative safe and effective therapy in knee OA, providing the possibility for home-based management of pain, compared with previous studies.”

[email protected]

In her role as the Dowager Countess on Public Broadcasting Service’s Downton Abbey, Maggie Smith has delivered many memorable one-liners, but none as revealing of her character’s social isolation as the clueless query, “What is a weekend?” How could anyone not appreciate the qualitative differences between the first 4 days of the week and the trio of Friday, Saturday, and Sunday?

A recent study by two Stanford University sociologists suggests that one doesn’t even need to have a job to place a higher value on the weekend (“You Don’t Need More Free Time,” by Cristobal Young, New York Times, Jan. 8, 2016). Using data from more than 500,000 respondents to a Gallup Daily Poll, the investigators found that a variety of indicators of well-being were lowest during the beginning of the workweek and then not surprisingly began to climb on Friday, reaching a peak on Saturday and Sunday. However, it turns out that the emotions of the unemployed respondents tracked exactly the same pattern as those of the people who had jobs.

In an effort to explain this unexpected finding, one of the investigators points out that time, particularly free time, is a “network good.” And in sociologist lingo, “Network goods are things that derive their value from being widely shared.” Although someone without a job may have an abundance of free time, the majority of the people with whom he or she could share that time are busy at work.

This study suggests that you may feel that you would be happier if you had more time off from work; part of the problem may be that there is a mismatch between your schedule and the schedules of the people and activities that you value most. You may have done this kind of self-assessment when you were looking for a job, but how successful were you in negotiating your schedule? Have you been able to renegotiate your schedule to match changes in your social situation? Spouse? Children?

How creative have you been in seeking out arrangements with coworkers who don’t share your time-off value profile? Although you might be tempted to say that based on this recent Stanford study, everyone places the same high value on weekend time off, is this really the case? There are a few people out there whose interests, personalities, and social situations make them value time off when you would just as soon work.

For example, I recently encountered a new word as I was scanning the classified advertisements in the back of this month’s Pediatrics. A hospital in California was looking for a “nocturnist.” An Internet search quickly confirmed my suspicion that a nocturnist is a physician, often a hospitalist, who prefers to work the night shift. Now, it may be just for the money, but if I were an avid birdwatcher, I can imagine wanting to maximize my time off when the sun was up.

Of course the trick is finding those coworkers whose lifestyles are as dissimilar from yours as possible ... and who are willing to trade work schedules. While I think that on many campuses, “diversity” has become an overused buzzword, diversity at your workplace might give you the best chance of finding a time-off arrangement that better matches your value profile.

Finally, if you are really unhappy, it may be time to swallow hard and entertain an arrangement in which you worked more and actually had less total free time, but the time you do have off is time you can share with the people you value and the activities you enjoy. It’s all about choosing the right set of compromises and learning to live with them. Good luck!

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

In her role as the Dowager Countess on Public Broadcasting Service’s Downton Abbey, Maggie Smith has delivered many memorable one-liners, but none as revealing of her character’s social isolation as the clueless query, “What is a weekend?” How could anyone not appreciate the qualitative differences between the first 4 days of the week and the trio of Friday, Saturday, and Sunday?

A recent study by two Stanford University sociologists suggests that one doesn’t even need to have a job to place a higher value on the weekend (“You Don’t Need More Free Time,” by Cristobal Young, New York Times, Jan. 8, 2016). Using data from more than 500,000 respondents to a Gallup Daily Poll, the investigators found that a variety of indicators of well-being were lowest during the beginning of the workweek and then not surprisingly began to climb on Friday, reaching a peak on Saturday and Sunday. However, it turns out that the emotions of the unemployed respondents tracked exactly the same pattern as those of the people who had jobs.

In an effort to explain this unexpected finding, one of the investigators points out that time, particularly free time, is a “network good.” And in sociologist lingo, “Network goods are things that derive their value from being widely shared.” Although someone without a job may have an abundance of free time, the majority of the people with whom he or she could share that time are busy at work.

This study suggests that you may feel that you would be happier if you had more time off from work; part of the problem may be that there is a mismatch between your schedule and the schedules of the people and activities that you value most. You may have done this kind of self-assessment when you were looking for a job, but how successful were you in negotiating your schedule? Have you been able to renegotiate your schedule to match changes in your social situation? Spouse? Children?

How creative have you been in seeking out arrangements with coworkers who don’t share your time-off value profile? Although you might be tempted to say that based on this recent Stanford study, everyone places the same high value on weekend time off, is this really the case? There are a few people out there whose interests, personalities, and social situations make them value time off when you would just as soon work.

For example, I recently encountered a new word as I was scanning the classified advertisements in the back of this month’s Pediatrics. A hospital in California was looking for a “nocturnist.” An Internet search quickly confirmed my suspicion that a nocturnist is a physician, often a hospitalist, who prefers to work the night shift. Now, it may be just for the money, but if I were an avid birdwatcher, I can imagine wanting to maximize my time off when the sun was up.

Of course the trick is finding those coworkers whose lifestyles are as dissimilar from yours as possible ... and who are willing to trade work schedules. While I think that on many campuses, “diversity” has become an overused buzzword, diversity at your workplace might give you the best chance of finding a time-off arrangement that better matches your value profile.

Finally, if you are really unhappy, it may be time to swallow hard and entertain an arrangement in which you worked more and actually had less total free time, but the time you do have off is time you can share with the people you value and the activities you enjoy. It’s all about choosing the right set of compromises and learning to live with them. Good luck!

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

In her role as the Dowager Countess on Public Broadcasting Service’s Downton Abbey, Maggie Smith has delivered many memorable one-liners, but none as revealing of her character’s social isolation as the clueless query, “What is a weekend?” How could anyone not appreciate the qualitative differences between the first 4 days of the week and the trio of Friday, Saturday, and Sunday?

A recent study by two Stanford University sociologists suggests that one doesn’t even need to have a job to place a higher value on the weekend (“You Don’t Need More Free Time,” by Cristobal Young, New York Times, Jan. 8, 2016). Using data from more than 500,000 respondents to a Gallup Daily Poll, the investigators found that a variety of indicators of well-being were lowest during the beginning of the workweek and then not surprisingly began to climb on Friday, reaching a peak on Saturday and Sunday. However, it turns out that the emotions of the unemployed respondents tracked exactly the same pattern as those of the people who had jobs.

In an effort to explain this unexpected finding, one of the investigators points out that time, particularly free time, is a “network good.” And in sociologist lingo, “Network goods are things that derive their value from being widely shared.” Although someone without a job may have an abundance of free time, the majority of the people with whom he or she could share that time are busy at work.

This study suggests that you may feel that you would be happier if you had more time off from work; part of the problem may be that there is a mismatch between your schedule and the schedules of the people and activities that you value most. You may have done this kind of self-assessment when you were looking for a job, but how successful were you in negotiating your schedule? Have you been able to renegotiate your schedule to match changes in your social situation? Spouse? Children?

How creative have you been in seeking out arrangements with coworkers who don’t share your time-off value profile? Although you might be tempted to say that based on this recent Stanford study, everyone places the same high value on weekend time off, is this really the case? There are a few people out there whose interests, personalities, and social situations make them value time off when you would just as soon work.

For example, I recently encountered a new word as I was scanning the classified advertisements in the back of this month’s Pediatrics. A hospital in California was looking for a “nocturnist.” An Internet search quickly confirmed my suspicion that a nocturnist is a physician, often a hospitalist, who prefers to work the night shift. Now, it may be just for the money, but if I were an avid birdwatcher, I can imagine wanting to maximize my time off when the sun was up.

Of course the trick is finding those coworkers whose lifestyles are as dissimilar from yours as possible ... and who are willing to trade work schedules. While I think that on many campuses, “diversity” has become an overused buzzword, diversity at your workplace might give you the best chance of finding a time-off arrangement that better matches your value profile.

Finally, if you are really unhappy, it may be time to swallow hard and entertain an arrangement in which you worked more and actually had less total free time, but the time you do have off is time you can share with the people you value and the activities you enjoy. It’s all about choosing the right set of compromises and learning to live with them. Good luck!

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics including “How to Say No to Your Toddler.”

To the Editor:

Infections caused by herpes simplex (HS) and herpes zoster (HZ) usually can be recognized by clinical findings; however, laboratory confirmation sometimes is required. Polymerase chain reaction (PCR) laboratory tests detect HS or HZ in a sensible and specific manner. New PCR systems such as real-time PCR (RT-PCR) give faster and more precise results. We report a case of recurrent concomitant HZ and HS diagnosed by RT-PCR.

A 62-year-old woman presented with recurrent painful cutaneous lesions on the left buttock and thigh of 9 years’ duration. This eruption was preceded by a burning sensation of 1 week’s duration that extended toward the heel. Cutaneous lesions normally were sparse and persisted for a few days. She also had annular erythematous lesions of 3 years’ duration on the upper trunk and shoulders after sun exposure. On physical examination, an atrophic hypopigmented patch was seen with a few vesicles located on the thigh. Whitish atrophic patches also were found in a linear distribution on the left buttock and thigh (Figure).

Laboratory results included the following: antinuclear antibody, 1:400 on a nuclear dotted pattern; extractable nuclear antigens (anti-Ro60 and anti-Ro52) were positive (reference range, >15); and rheumatoid factor was 24.1 U/mL (reference range, 0–15 U/mL). The patient did not meet any other American College of Rheumatology criteria^1,2 of systemic lupus erythematosus apart from photosensitivity. The rest of the analysis—complete blood cell count, liver enzymes, and biochemistry—was normal or negative. Human immunodeficiency virus, herpes simplex virus types 1 and 2 (HHV-1 and HHV-2), and varicella-zoster virus (VZV) IgM serologies were negative, whereas IgG VZV serology was positive.

The microbiological study via swab obtained from the roof and fluid from the vesicles showed an indeterminate result from the rapid direct antigen detection with immunofluorescent antibodies. Viral cultures were HHV-2 positive and VZV negative. Conventional PCR showed positive results, both for HHV-2 and VZV. A second analysis, performed with RT-PCR from a new sample taken 2 months later, showed the same results, which led to the diagnosis of recurrent concomitant HS and HZ with a recurrent HZ clinical pattern. The patient was started on valacyclovir 1 g daily, and the number and intensity of flares diminished in the months following treatment.

Concomitant HS and HZ on the same dermatome has been described in the literature.^3,4 In a retrospective series of 20 immunocompetent patients, HZ was the main presumed diagnosis before laboratory confirmation of diagnosis, and only 1 case corresponded to recurrent HZ.³ Other cases of simultaneous HS and HZ have been described, but they did not occur on the same dermatome. Half of these reported cases were in immunosuppressed patients.^5,6

The recurrent nature of HS is well known; however, recurrent cases of HZ are rare. Nevertheless, in a population-based cohort study of patients with a confirmed prior episode of HZ (N=1669), recurrences were found in 6% of patients.⁷ Recurrence was more common if the patient was immunosuppressed, was female and 50 years or older, and had pain for more than 30 days.⁷

The recurrence rate was high in our case, but no immunosuppressive factor could be found apart from probable subacute cutaneous lupus erythematosus. Systemic lupus erythematosus has been associated with a high risk for developing HZ secondary to cell-mediated immunosuppression. The annual incidence of HZ can reach 32 of 1000 patients with systemic lupus erythematosus, while in the general population the incidence is only 1.5 to 3 of 1000 patients.^8-10

Direct detection of antigens of HS and HZ is a fast and inexpensive technique but lacks the sensitivity of viral cultures. Viral cultures used to be considered the gold standard; however, they are less sensitive than PCR.¹¹ Furthermore, VZV detection is more difficult than HS, leading to a notable percentage of false-negative results.¹² Polymerase chain reaction is a fast, reliable, and sensitive laboratory technique. Real-time PCR permits faster results than conventional PCR, specifically for HHV-1, HHV-2, and HZ detection. It also has minimal risk for contamination.^13,14 In our opinion, PCR should be the gold standard instead of viral cultures. It has proven its superiority as a rapid method for detection, it is the most sensitive test, it is easier to perform, and it is cost effective (Table).^11,15-19 However, viral cultures can allow sensitivity testing and are still an option for determination of susceptibility to antivirals.

In our case, a false-positive was excluded because no sign of possible contamination was found, repeated internal analysis from the same sample confirmed the results, and a new analysis from a new flare showed the same results 2 months later. However, we cannot rule out that the positivity for HZ of the second sample was due to the high sensitivity of the test and a virus latency in nerves.

We propose the use of PCR as a method of choice. Presumably more cases of recurrent HZ and concomitant HS and HZ will be seen with PCR use. In the case of a concomitant infection of HS and HZ, it is reasonable to use an antiviral dosage as in HZ treatment. No literature regarding outcomes from therapy could be found.

To the Editor:

Infections caused by herpes simplex (HS) and herpes zoster (HZ) usually can be recognized by clinical findings; however, laboratory confirmation sometimes is required. Polymerase chain reaction (PCR) laboratory tests detect HS or HZ in a sensible and specific manner. New PCR systems such as real-time PCR (RT-PCR) give faster and more precise results. We report a case of recurrent concomitant HZ and HS diagnosed by RT-PCR.

A 62-year-old woman presented with recurrent painful cutaneous lesions on the left buttock and thigh of 9 years’ duration. This eruption was preceded by a burning sensation of 1 week’s duration that extended toward the heel. Cutaneous lesions normally were sparse and persisted for a few days. She also had annular erythematous lesions of 3 years’ duration on the upper trunk and shoulders after sun exposure. On physical examination, an atrophic hypopigmented patch was seen with a few vesicles located on the thigh. Whitish atrophic patches also were found in a linear distribution on the left buttock and thigh (Figure).

Laboratory results included the following: antinuclear antibody, 1:400 on a nuclear dotted pattern; extractable nuclear antigens (anti-Ro60 and anti-Ro52) were positive (reference range, >15); and rheumatoid factor was 24.1 U/mL (reference range, 0–15 U/mL). The patient did not meet any other American College of Rheumatology criteria^1,2 of systemic lupus erythematosus apart from photosensitivity. The rest of the analysis—complete blood cell count, liver enzymes, and biochemistry—was normal or negative. Human immunodeficiency virus, herpes simplex virus types 1 and 2 (HHV-1 and HHV-2), and varicella-zoster virus (VZV) IgM serologies were negative, whereas IgG VZV serology was positive.

The microbiological study via swab obtained from the roof and fluid from the vesicles showed an indeterminate result from the rapid direct antigen detection with immunofluorescent antibodies. Viral cultures were HHV-2 positive and VZV negative. Conventional PCR showed positive results, both for HHV-2 and VZV. A second analysis, performed with RT-PCR from a new sample taken 2 months later, showed the same results, which led to the diagnosis of recurrent concomitant HS and HZ with a recurrent HZ clinical pattern. The patient was started on valacyclovir 1 g daily, and the number and intensity of flares diminished in the months following treatment.

Concomitant HS and HZ on the same dermatome has been described in the literature.^3,4 In a retrospective series of 20 immunocompetent patients, HZ was the main presumed diagnosis before laboratory confirmation of diagnosis, and only 1 case corresponded to recurrent HZ.³ Other cases of simultaneous HS and HZ have been described, but they did not occur on the same dermatome. Half of these reported cases were in immunosuppressed patients.^5,6

The recurrent nature of HS is well known; however, recurrent cases of HZ are rare. Nevertheless, in a population-based cohort study of patients with a confirmed prior episode of HZ (N=1669), recurrences were found in 6% of patients.⁷ Recurrence was more common if the patient was immunosuppressed, was female and 50 years or older, and had pain for more than 30 days.⁷

The recurrence rate was high in our case, but no immunosuppressive factor could be found apart from probable subacute cutaneous lupus erythematosus. Systemic lupus erythematosus has been associated with a high risk for developing HZ secondary to cell-mediated immunosuppression. The annual incidence of HZ can reach 32 of 1000 patients with systemic lupus erythematosus, while in the general population the incidence is only 1.5 to 3 of 1000 patients.^8-10

Direct detection of antigens of HS and HZ is a fast and inexpensive technique but lacks the sensitivity of viral cultures. Viral cultures used to be considered the gold standard; however, they are less sensitive than PCR.¹¹ Furthermore, VZV detection is more difficult than HS, leading to a notable percentage of false-negative results.¹² Polymerase chain reaction is a fast, reliable, and sensitive laboratory technique. Real-time PCR permits faster results than conventional PCR, specifically for HHV-1, HHV-2, and HZ detection. It also has minimal risk for contamination.^13,14 In our opinion, PCR should be the gold standard instead of viral cultures. It has proven its superiority as a rapid method for detection, it is the most sensitive test, it is easier to perform, and it is cost effective (Table).^11,15-19 However, viral cultures can allow sensitivity testing and are still an option for determination of susceptibility to antivirals.

In our case, a false-positive was excluded because no sign of possible contamination was found, repeated internal analysis from the same sample confirmed the results, and a new analysis from a new flare showed the same results 2 months later. However, we cannot rule out that the positivity for HZ of the second sample was due to the high sensitivity of the test and a virus latency in nerves.

We propose the use of PCR as a method of choice. Presumably more cases of recurrent HZ and concomitant HS and HZ will be seen with PCR use. In the case of a concomitant infection of HS and HZ, it is reasonable to use an antiviral dosage as in HZ treatment. No literature regarding outcomes from therapy could be found.

To the Editor:

Infections caused by herpes simplex (HS) and herpes zoster (HZ) usually can be recognized by clinical findings; however, laboratory confirmation sometimes is required. Polymerase chain reaction (PCR) laboratory tests detect HS or HZ in a sensible and specific manner. New PCR systems such as real-time PCR (RT-PCR) give faster and more precise results. We report a case of recurrent concomitant HZ and HS diagnosed by RT-PCR.

A 62-year-old woman presented with recurrent painful cutaneous lesions on the left buttock and thigh of 9 years’ duration. This eruption was preceded by a burning sensation of 1 week’s duration that extended toward the heel. Cutaneous lesions normally were sparse and persisted for a few days. She also had annular erythematous lesions of 3 years’ duration on the upper trunk and shoulders after sun exposure. On physical examination, an atrophic hypopigmented patch was seen with a few vesicles located on the thigh. Whitish atrophic patches also were found in a linear distribution on the left buttock and thigh (Figure).

Laboratory results included the following: antinuclear antibody, 1:400 on a nuclear dotted pattern; extractable nuclear antigens (anti-Ro60 and anti-Ro52) were positive (reference range, >15); and rheumatoid factor was 24.1 U/mL (reference range, 0–15 U/mL). The patient did not meet any other American College of Rheumatology criteria^1,2 of systemic lupus erythematosus apart from photosensitivity. The rest of the analysis—complete blood cell count, liver enzymes, and biochemistry—was normal or negative. Human immunodeficiency virus, herpes simplex virus types 1 and 2 (HHV-1 and HHV-2), and varicella-zoster virus (VZV) IgM serologies were negative, whereas IgG VZV serology was positive.

The microbiological study via swab obtained from the roof and fluid from the vesicles showed an indeterminate result from the rapid direct antigen detection with immunofluorescent antibodies. Viral cultures were HHV-2 positive and VZV negative. Conventional PCR showed positive results, both for HHV-2 and VZV. A second analysis, performed with RT-PCR from a new sample taken 2 months later, showed the same results, which led to the diagnosis of recurrent concomitant HS and HZ with a recurrent HZ clinical pattern. The patient was started on valacyclovir 1 g daily, and the number and intensity of flares diminished in the months following treatment.

Concomitant HS and HZ on the same dermatome has been described in the literature.^3,4 In a retrospective series of 20 immunocompetent patients, HZ was the main presumed diagnosis before laboratory confirmation of diagnosis, and only 1 case corresponded to recurrent HZ.³ Other cases of simultaneous HS and HZ have been described, but they did not occur on the same dermatome. Half of these reported cases were in immunosuppressed patients.^5,6

The recurrent nature of HS is well known; however, recurrent cases of HZ are rare. Nevertheless, in a population-based cohort study of patients with a confirmed prior episode of HZ (N=1669), recurrences were found in 6% of patients.⁷ Recurrence was more common if the patient was immunosuppressed, was female and 50 years or older, and had pain for more than 30 days.⁷

The recurrence rate was high in our case, but no immunosuppressive factor could be found apart from probable subacute cutaneous lupus erythematosus. Systemic lupus erythematosus has been associated with a high risk for developing HZ secondary to cell-mediated immunosuppression. The annual incidence of HZ can reach 32 of 1000 patients with systemic lupus erythematosus, while in the general population the incidence is only 1.5 to 3 of 1000 patients.^8-10

Direct detection of antigens of HS and HZ is a fast and inexpensive technique but lacks the sensitivity of viral cultures. Viral cultures used to be considered the gold standard; however, they are less sensitive than PCR.¹¹ Furthermore, VZV detection is more difficult than HS, leading to a notable percentage of false-negative results.¹² Polymerase chain reaction is a fast, reliable, and sensitive laboratory technique. Real-time PCR permits faster results than conventional PCR, specifically for HHV-1, HHV-2, and HZ detection. It also has minimal risk for contamination.^13,14 In our opinion, PCR should be the gold standard instead of viral cultures. It has proven its superiority as a rapid method for detection, it is the most sensitive test, it is easier to perform, and it is cost effective (Table).^11,15-19 However, viral cultures can allow sensitivity testing and are still an option for determination of susceptibility to antivirals.

In our case, a false-positive was excluded because no sign of possible contamination was found, repeated internal analysis from the same sample confirmed the results, and a new analysis from a new flare showed the same results 2 months later. However, we cannot rule out that the positivity for HZ of the second sample was due to the high sensitivity of the test and a virus latency in nerves.

We propose the use of PCR as a method of choice. Presumably more cases of recurrent HZ and concomitant HS and HZ will be seen with PCR use. In the case of a concomitant infection of HS and HZ, it is reasonable to use an antiviral dosage as in HZ treatment. No literature regarding outcomes from therapy could be found.

Today, “normal” aging is no longer acceptable. From aesthetics to physical, mental, and sexual health, the maturing population seeks effective minimally invasive and practical methods to halt time and reverse its adverse effects. Nowhere is this more apparent than when dealing with urinary and fecal incontinence, conditions that can be not only embarrassing to patients but also debilitating, with potential crippling adverse affects on quality of life. As the US population ages, the prevalence of incontinence is increasing.

Patients commonly present with questions about their incontinence with preconceived notions on their available treatment options based on Internet searches and advertisements from magazines and television. Thus, as gynecologists, we have a pivotal role in educating women on their conditions and management options in a comprehensive, informative, and reassuring manner. By educating patients on the success rates and limitations of available treatments, patients can make informed decisions and reinforce their sense of autonomy. In this article we present the evidence on current, new, and investigative products available for the treatment of both stress urinary incontinence and overactive bladder, as well as fecal incontinence.

Case 1: Stress urinary incontinence
A 46-year-old woman (G2P2) presents with loss of urine with exercise, dancing, and sneezing that began after the birth of her last baby 5 years ago and is progressively becoming more frequent. She performs Kegel exercises occasionally and denies urinary urgency and/or urge incontinence. She reports a 20-lb weight gain in the past 3 years. Physical examination findings reveal normal pelvic examination with adequate pelvic organ support but weakened pelvic floor muscles during contraction. When you ask her to cough, you observe a small amount of urine loss from the urethral meatus. She has heard of “slings” before, but she is anxious about surgery.

Stress urinary incontinence (SUI) is the involuntary loss of urine with effort, physical exertion, sneezing, or coughing.¹ It is the most common type of incontinence in younger women, with risk factors including increasing age, parity, and obesity.^2,3 SUI treatment options, beginning from least to most invasive, include pelvic floor exercises, biofeedback and/or physical therapy, continence devices, off-label use of medications, urethral bulking agents, and surgical correction with slings. Midurethral tension-free slings are highly efficacious for the treatment of SUI. While a sling is a minimally invasive procedure, patients typically voice concerns regarding surgery and appropriately begin with conservative treatments.

A new FDA-approved OTC option for SUI
First-line conservative therapies offered to patients for SUI include pelvic floor muscle exercises and intravaginal continence devices. Disappointingly, such devices—including pessaries and the incontinence dish—have not been popular among patients for SUI. Authors of a randomized control trial evaluating incontinence pessaries versus behavioral therapy, including pelvic floor muscle training, found that, after 3 months, use of a pes‑ sary was not as effective as behavioral therapy in terms of patient satisfaction and improvement in bothersome urinary incontinence.⁴ In our experience, many patients wearing incontinence rings discontinue their use due to ineffectiveness or discomfort.

Patients now have an FDA-approved, over-the-counter option for SUI symptom management. The Poise Impressa is a disposable, nonabsorbent, flexible intravaginal device for patients with SUI (FIGURE 1). The device is comprised of a silicone core with a soft, nonwoven polypropylene fabric cover. It is inserted similar to a tampon, using an applicator, and provides nonobstructive support to the urethra to prevent stress urinary leakage. To find the proper fit, patients purchase the sizing kit, which includes 3 sizes. Patients are to insert size 1 first and monitor their comfort as well as improvement in leakage. Should size 1not sufficiently relieve leakage, the patient may try sizes 2 and 3 successively, with the goal of finding the most comfortable and effective insert. The insert is approved for up to 8 hours of wear in a 24-hour period, at which time the patient removes the device by pulling the string in a similar manner as removing a tampon.

Efficacy and quality of life data. Over 28 days, 85% of women with severe SUI confirmed on urodynamic testing achieved greater than 70% leakage reduction according to measured pad weights.⁵ Seventy percent of women reported 90% improvement in quality of life using validated questionnaires. In addition, 92% reported feeling dry with an improved perception of incontinence and greater confidence during strenuous activities.⁶ There were no serious adverse events, and the most common mild adverse events were discomfort, pain, and spotting.

As more patients become aware of the device through advertising and word of mouth, we expect patients to seek advice from their gynecologists on the safety and efficacy of the insert. In our experience, most patients report improvement in bothersome symptoms with the device and are overall satisfied. For patients who have discomfort with device placement, a water-based lubricant can be used. Patients using vaginal estrogen may apply the medication at night and wear the device during the day.

Office-based bladder control system in the pipeline
For SUI, options are limited for patients who would rather seek office-based procedures than invasive surgeries. Injections of urethral bulking agents can be performed in an office setting by injecting them transurethrally with a cystoscope slightly distal to the bladder neck. While bulking agents have a role in certain patients with SUI, especially those who are not interested in pursuing more invasive surgeries, only 43% have short-term (less than 6 months) cure and 75% report short-term improvement.⁷

A minimally invasive office-based procedure to treat SUI symptoms is under investigation in clinical trials currently. The Vesair Balloon bladder control system (Solace Therapeutics) is performed with cystoscopic guidance and is being tested at multiple sites throughout the United States (FIGURE 2).

The Vesair Balloon acts like a “shock absorber” to reduce momentary increases in bladder pressure due to external forces or stressors. The balloon is a small device, approximately the size of a quarter, and is implanted through the urethra via a specially designed applicator under cystoscopic guidance in the office setting. Pretreatment with pain medication usually is unnecessary. The VesairBalloon may be retained in situ for up to 12 months, at which time it is removed using a device-specific grasper under direct visualization with a cystoscope in the office.

Preliminary efficacy and safety data. In a single-blinded randomized controlled trial, 63% of women in the Vesair Balloon group had significant improvement in provocative pad weights and quality-of-life questionnaire scores at 3 months, compared with 31% in the control group.⁸ No serious adverse events were observed. Eleven of 63 patients (17%) withdrew from the study—most commonly for bladder irritation and dysuria.

We anxiously await the results of a second single-blinded randomized control trial currently being conducted.

Best surgical options for SUI
Today, the standard surgical procedure for SUI is a midurethral sling. Midurethral slings may be placed through 3 routes: retropubic; transobturator; and single-incision, otherwise known as “mini-slings.” Subjective cure rates of retropubic versus transobturator slings are similar, with lower rates of bladder perforation, major vascular/visceral injury, and operative blood loss in the transobturator group.⁹ However, rates of groin pain are higher in the trans‑ obturator group.

Single-incision slings were developed in an effort to avoid the morbidity and pain with passing traditional sling trocars through the obturator space and skin of the groin. In a randomized controlled trial, the Miniarc single- incision sling (Astora Women’s Health) was found to be noninferior to the Monarc transobturator sling (Astora) at 12 and 36 months.¹⁰ There were no statistically significant differences between subjective and objective cure rates on cough stress tests. Postoperative pain and groin pain were significantly less in patients with the Miniarc sling, compared with the Monarc sling.

It is our opinion that as more data become available, single-incision slings will find their foothold in a subset of patients with SUI.

Case 2: Overactive bladder: Failed medication therapy
A healthy 63-year-old woman presents with a 9-month history of loss of urine with strong urges, urinating 4 times per night, and a feeling of urgency when she needs to urinate. She denies pain with urination, difficulty emptying her bladder fully, and pain with a full bladder. She has restricted her fluid intake to 4 glasses of water per day and has stopped drinking fluids 4 hours before bedtime.

She described her symptoms to her intern‑ ist, who prescribed oxybutynin. She took the medication for 3 months but stopped after she developed severe constipation and dry mouth. She states the medication did not help her urinary symptoms. You discuss with her trials of other medications including topical anticholinergics and mirabegron. She is frustrated with her symptoms and asks if there are any other options besides medications.

Overactive bladder (OAB) is present in up to 16% of the US population, with the percentage estimated to increase by 20% within the next 2 years.^11,12 The drastic increase in prevalence, likely due to the aging population, may result in an increased counseling and management burden placed on general practitioners and gynecologists.

First-line management options for OAB are behavioral modifications and/or medications. Our patient in case 2 failed both first-line therapies. When a patient fails or is intolerant to an anticholinergic medication, we offer mirabegron, a beta-3 agonist (after excluding any contraindications to the medication). Beyond medications, the therapeutic options are rather limited.

Second-line OAB treatment options
In January 2013, the FDA expanded the approved use of onabotulinum toxin A (Botox, Allergan) for the treatment of OAB in those who are intolerant of or have failed treatment with anticholinergic medications. Using a cystoscope, 100 units of onabotulinum toxin A are injected into 20 sites within the bladder wall. Due to the risk of urinary retention in up to 6% of patients, it is recommended to administer onabotulinum toxin A to patients who are willing and capable of performing clean intermittent catheterization.¹³

Efficacy data. In a recent systematic review and meta-analysis, the authors concluded onabotulinum toxin A to be effective in the treatment of idiopathic OAB with a statistically significant reduction compared with baseline in the number of incontinence episodes per day (-2.77 in the treatment group vs -1.01 in the placebo group) and the number of voids per day (-1.61 in the treatment group vs -0.87 in the placebo group).¹⁴ Patients who received onabotulinum toxin A experienced a higher rate of adverse effects, such as urinary tract infections, and were more likely to require clean intermittent catheterization due to incomplete bladder emptying.¹³ Patients can expect symptom improvement for approximately 6 months or longer.¹⁵ Based on the manufacturers’ recommendations, patients are not to be reinjected sooner than 12 weeks from prior onabotulinum toxin A injection.

In women with refractory OAB, available second-line treatments include neuromodulation by sacral nerve or posterior tibial nerve stimulation (PTNS). The latter therapy is an office-based procedure that involves placement of a lead percutaneous to the medial aspect of the ankle near the tibial nerve. It is postulated that stimulation of the tibial nerve results in retrograde stimulation of the S3 sacral nerve plexus, resulting in OAB symptom relief in 54% to 70% of patients.¹⁶

Case 3: Fecal incontinence
A 57-year-old, otherwise healthy, multiparous woman presents with a 3-year history of fecal incontinence. She reports that it is embarrassing and distressing. She avoids certain social activities and is not currently sexually active due to the frequency of bowel leakage episodes.

In an effort to decrease her episodes of incontinence, she takes loperamide hydrochloride (Imodium) regularly with little improvement in the frequency of accidents. She has no history of gastrointestinal, rectal, or gynecologic surgery. She had 2 full-term vaginal deliveries that were uncomplicated. On review of systems, she also discloses occasional urinary incontinence.

Physical examination reveals normal vaginal anatomy with adequate pelvic organ support and no neurologic abnormalities. Rectal examination demonstrates normal tone and no evidence of rectal prolapse. Contractions of the pelvic floor muscles are weak. She is frustrated with her condition and seeks your guidance.

Fecal incontinence affects more than 20 million women in the United States, with only one-third of those with the condition disclosing their symptoms to their physician.¹⁷ Many etiologies for accidental bowel leakage exist, with some of the most common being advancing age and obstetric trauma. Up to one-third of women presenting for evaluation of urinary incontinence have fecal incontinence; therefore, one must be vigilant in screening for this potentially devastating condition.¹⁸

In case 3, the patient has tried medical therapies for fecal incontinence, including stool-bulking agents and motility regulators such as loperamide hydrochloride. Besides offering fiber supplements (or other stool-bulking agents) or physical therapy, nonsurgical options for this patient are limited.

Newly available: A vaginal insert for fecal incontinence
In 2015, the Eclipse System (Pelvalon) became the first FDA-approved vaginal insert for the treatment of fecal incontinence. The manufacturer recently was granted clearance for its second-generation device (FIGURE 3). The device consists of a silicone-coated stainless steel base with a posteriorly facing balloon and a pressure-regulated pump that allows the patient to control her bowel movements. After a patient is fitted with the device in the office setting, she is independently able to insert and remove it as well as deflate the balloon to allow for bowel movements and inflate the balloon to prevent accidental bowel leakage.

In a multicenter trial conducted by Richter and colleagues,¹⁹ 78% of women successfully fitted with the device had a 50% mean reduction of fecal incontinence episodes. Two-week mean incontinence episodes decreased from 11 to 2 after 1 month of continued use of the insert. In addition, there was significant improvement in quality-of-life questionnaire scores.

Of the 110 patients fitted with the device, 32 (29%) withdrew due to unsatisfactory device fit or were unable to remove or insert the device themselves. Common adverse effects included pelvic cramping and discomfort during device fitting. One month after insertion, pelvic pain and cramping continued in up to 10% of patients. No serious adverse events related to the device were observed during the 1-month trial.¹⁹

In the approximate 70% of women successfully fitted with the vaginal insert, the system was highly efficacious in improving subjective and objective outcomes with no unexpected serious adverse events. Currently the device is available at investigative sites across the United States, and the company plans for sales to begin later this year.

Surgical options for fecal incontinence
In patients for whom conservative and medical therapies have failed, surgical treatments may be offered. Surgical options vary from minimally invasive procedures to colostomy. One of the minimally invasive procedures available is the InterStim procedure, or sacral nerve stimulation (SNS). An electrode is inserted percutaneously through the S3 foramen and is connected to an implanted battery under the skin of the buttocks. Low-voltage stimulation is applied to the leads that lie adjacent to the S3 sacral nerve roots.

Patients with SNS experience fewer episodes of fecal incontinence, with over 80% maintaining a reduction in fecal incontinent episodes by greater than 50% up to 5 years after implantation.^20,21

The transobturator postanal sling system (TOPAS, Astora) is a new investigational surgical device. It is inserted in a minimally invasive procedure and is currently undergoing a prospective, multicenter clinical trial (FIGURE 4). It consists of a polypropylene mesh sling placed perianally, with the mesh arms exiting through the obturator foramen bilaterally. It is intended to increase posterior pelvic support at the level of the anorectal junction. Efficacy and safety of the product have yet to be determined.

We need to stay up to date on new treatment options
As the prevalence increases for urinary and fecal incontinence, ObGyns are challenged to remain knowledgeable about the condition, the prognosis, and the success of interventions. Currently, patients have a range of options to manage their urinary and fecal incontinence symptoms, with the number of products and clinical data increasing over time. With the advent of novel products and the widespread availability of information via the Internet, physicians must remain the established source on new innovative treatments and up-to-date clinical data in order to provide competent and comprehensive care.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Today, “normal” aging is no longer acceptable. From aesthetics to physical, mental, and sexual health, the maturing population seeks effective minimally invasive and practical methods to halt time and reverse its adverse effects. Nowhere is this more apparent than when dealing with urinary and fecal incontinence, conditions that can be not only embarrassing to patients but also debilitating, with potential crippling adverse affects on quality of life. As the US population ages, the prevalence of incontinence is increasing.

Patients commonly present with questions about their incontinence with preconceived notions on their available treatment options based on Internet searches and advertisements from magazines and television. Thus, as gynecologists, we have a pivotal role in educating women on their conditions and management options in a comprehensive, informative, and reassuring manner. By educating patients on the success rates and limitations of available treatments, patients can make informed decisions and reinforce their sense of autonomy. In this article we present the evidence on current, new, and investigative products available for the treatment of both stress urinary incontinence and overactive bladder, as well as fecal incontinence.

Case 1: Stress urinary incontinence
A 46-year-old woman (G2P2) presents with loss of urine with exercise, dancing, and sneezing that began after the birth of her last baby 5 years ago and is progressively becoming more frequent. She performs Kegel exercises occasionally and denies urinary urgency and/or urge incontinence. She reports a 20-lb weight gain in the past 3 years. Physical examination findings reveal normal pelvic examination with adequate pelvic organ support but weakened pelvic floor muscles during contraction. When you ask her to cough, you observe a small amount of urine loss from the urethral meatus. She has heard of “slings” before, but she is anxious about surgery.

Stress urinary incontinence (SUI) is the involuntary loss of urine with effort, physical exertion, sneezing, or coughing.¹ It is the most common type of incontinence in younger women, with risk factors including increasing age, parity, and obesity.^2,3 SUI treatment options, beginning from least to most invasive, include pelvic floor exercises, biofeedback and/or physical therapy, continence devices, off-label use of medications, urethral bulking agents, and surgical correction with slings. Midurethral tension-free slings are highly efficacious for the treatment of SUI. While a sling is a minimally invasive procedure, patients typically voice concerns regarding surgery and appropriately begin with conservative treatments.

A new FDA-approved OTC option for SUI
First-line conservative therapies offered to patients for SUI include pelvic floor muscle exercises and intravaginal continence devices. Disappointingly, such devices—including pessaries and the incontinence dish—have not been popular among patients for SUI. Authors of a randomized control trial evaluating incontinence pessaries versus behavioral therapy, including pelvic floor muscle training, found that, after 3 months, use of a pes‑ sary was not as effective as behavioral therapy in terms of patient satisfaction and improvement in bothersome urinary incontinence.⁴ In our experience, many patients wearing incontinence rings discontinue their use due to ineffectiveness or discomfort.

Patients now have an FDA-approved, over-the-counter option for SUI symptom management. The Poise Impressa is a disposable, nonabsorbent, flexible intravaginal device for patients with SUI (FIGURE 1). The device is comprised of a silicone core with a soft, nonwoven polypropylene fabric cover. It is inserted similar to a tampon, using an applicator, and provides nonobstructive support to the urethra to prevent stress urinary leakage. To find the proper fit, patients purchase the sizing kit, which includes 3 sizes. Patients are to insert size 1 first and monitor their comfort as well as improvement in leakage. Should size 1not sufficiently relieve leakage, the patient may try sizes 2 and 3 successively, with the goal of finding the most comfortable and effective insert. The insert is approved for up to 8 hours of wear in a 24-hour period, at which time the patient removes the device by pulling the string in a similar manner as removing a tampon.

Efficacy and quality of life data. Over 28 days, 85% of women with severe SUI confirmed on urodynamic testing achieved greater than 70% leakage reduction according to measured pad weights.⁵ Seventy percent of women reported 90% improvement in quality of life using validated questionnaires. In addition, 92% reported feeling dry with an improved perception of incontinence and greater confidence during strenuous activities.⁶ There were no serious adverse events, and the most common mild adverse events were discomfort, pain, and spotting.

As more patients become aware of the device through advertising and word of mouth, we expect patients to seek advice from their gynecologists on the safety and efficacy of the insert. In our experience, most patients report improvement in bothersome symptoms with the device and are overall satisfied. For patients who have discomfort with device placement, a water-based lubricant can be used. Patients using vaginal estrogen may apply the medication at night and wear the device during the day.

Office-based bladder control system in the pipeline
For SUI, options are limited for patients who would rather seek office-based procedures than invasive surgeries. Injections of urethral bulking agents can be performed in an office setting by injecting them transurethrally with a cystoscope slightly distal to the bladder neck. While bulking agents have a role in certain patients with SUI, especially those who are not interested in pursuing more invasive surgeries, only 43% have short-term (less than 6 months) cure and 75% report short-term improvement.⁷

A minimally invasive office-based procedure to treat SUI symptoms is under investigation in clinical trials currently. The Vesair Balloon bladder control system (Solace Therapeutics) is performed with cystoscopic guidance and is being tested at multiple sites throughout the United States (FIGURE 2).

The Vesair Balloon acts like a “shock absorber” to reduce momentary increases in bladder pressure due to external forces or stressors. The balloon is a small device, approximately the size of a quarter, and is implanted through the urethra via a specially designed applicator under cystoscopic guidance in the office setting. Pretreatment with pain medication usually is unnecessary. The VesairBalloon may be retained in situ for up to 12 months, at which time it is removed using a device-specific grasper under direct visualization with a cystoscope in the office.

Preliminary efficacy and safety data. In a single-blinded randomized controlled trial, 63% of women in the Vesair Balloon group had significant improvement in provocative pad weights and quality-of-life questionnaire scores at 3 months, compared with 31% in the control group.⁸ No serious adverse events were observed. Eleven of 63 patients (17%) withdrew from the study—most commonly for bladder irritation and dysuria.

We anxiously await the results of a second single-blinded randomized control trial currently being conducted.

Best surgical options for SUI
Today, the standard surgical procedure for SUI is a midurethral sling. Midurethral slings may be placed through 3 routes: retropubic; transobturator; and single-incision, otherwise known as “mini-slings.” Subjective cure rates of retropubic versus transobturator slings are similar, with lower rates of bladder perforation, major vascular/visceral injury, and operative blood loss in the transobturator group.⁹ However, rates of groin pain are higher in the trans‑ obturator group.

Single-incision slings were developed in an effort to avoid the morbidity and pain with passing traditional sling trocars through the obturator space and skin of the groin. In a randomized controlled trial, the Miniarc single- incision sling (Astora Women’s Health) was found to be noninferior to the Monarc transobturator sling (Astora) at 12 and 36 months.¹⁰ There were no statistically significant differences between subjective and objective cure rates on cough stress tests. Postoperative pain and groin pain were significantly less in patients with the Miniarc sling, compared with the Monarc sling.

It is our opinion that as more data become available, single-incision slings will find their foothold in a subset of patients with SUI.

Case 2: Overactive bladder: Failed medication therapy
A healthy 63-year-old woman presents with a 9-month history of loss of urine with strong urges, urinating 4 times per night, and a feeling of urgency when she needs to urinate. She denies pain with urination, difficulty emptying her bladder fully, and pain with a full bladder. She has restricted her fluid intake to 4 glasses of water per day and has stopped drinking fluids 4 hours before bedtime.

She described her symptoms to her intern‑ ist, who prescribed oxybutynin. She took the medication for 3 months but stopped after she developed severe constipation and dry mouth. She states the medication did not help her urinary symptoms. You discuss with her trials of other medications including topical anticholinergics and mirabegron. She is frustrated with her symptoms and asks if there are any other options besides medications.

Overactive bladder (OAB) is present in up to 16% of the US population, with the percentage estimated to increase by 20% within the next 2 years.^11,12 The drastic increase in prevalence, likely due to the aging population, may result in an increased counseling and management burden placed on general practitioners and gynecologists.

First-line management options for OAB are behavioral modifications and/or medications. Our patient in case 2 failed both first-line therapies. When a patient fails or is intolerant to an anticholinergic medication, we offer mirabegron, a beta-3 agonist (after excluding any contraindications to the medication). Beyond medications, the therapeutic options are rather limited.

Second-line OAB treatment options
In January 2013, the FDA expanded the approved use of onabotulinum toxin A (Botox, Allergan) for the treatment of OAB in those who are intolerant of or have failed treatment with anticholinergic medications. Using a cystoscope, 100 units of onabotulinum toxin A are injected into 20 sites within the bladder wall. Due to the risk of urinary retention in up to 6% of patients, it is recommended to administer onabotulinum toxin A to patients who are willing and capable of performing clean intermittent catheterization.¹³

Efficacy data. In a recent systematic review and meta-analysis, the authors concluded onabotulinum toxin A to be effective in the treatment of idiopathic OAB with a statistically significant reduction compared with baseline in the number of incontinence episodes per day (-2.77 in the treatment group vs -1.01 in the placebo group) and the number of voids per day (-1.61 in the treatment group vs -0.87 in the placebo group).¹⁴ Patients who received onabotulinum toxin A experienced a higher rate of adverse effects, such as urinary tract infections, and were more likely to require clean intermittent catheterization due to incomplete bladder emptying.¹³ Patients can expect symptom improvement for approximately 6 months or longer.¹⁵ Based on the manufacturers’ recommendations, patients are not to be reinjected sooner than 12 weeks from prior onabotulinum toxin A injection.

In women with refractory OAB, available second-line treatments include neuromodulation by sacral nerve or posterior tibial nerve stimulation (PTNS). The latter therapy is an office-based procedure that involves placement of a lead percutaneous to the medial aspect of the ankle near the tibial nerve. It is postulated that stimulation of the tibial nerve results in retrograde stimulation of the S3 sacral nerve plexus, resulting in OAB symptom relief in 54% to 70% of patients.¹⁶

Case 3: Fecal incontinence
A 57-year-old, otherwise healthy, multiparous woman presents with a 3-year history of fecal incontinence. She reports that it is embarrassing and distressing. She avoids certain social activities and is not currently sexually active due to the frequency of bowel leakage episodes.

In an effort to decrease her episodes of incontinence, she takes loperamide hydrochloride (Imodium) regularly with little improvement in the frequency of accidents. She has no history of gastrointestinal, rectal, or gynecologic surgery. She had 2 full-term vaginal deliveries that were uncomplicated. On review of systems, she also discloses occasional urinary incontinence.

Physical examination reveals normal vaginal anatomy with adequate pelvic organ support and no neurologic abnormalities. Rectal examination demonstrates normal tone and no evidence of rectal prolapse. Contractions of the pelvic floor muscles are weak. She is frustrated with her condition and seeks your guidance.

Fecal incontinence affects more than 20 million women in the United States, with only one-third of those with the condition disclosing their symptoms to their physician.¹⁷ Many etiologies for accidental bowel leakage exist, with some of the most common being advancing age and obstetric trauma. Up to one-third of women presenting for evaluation of urinary incontinence have fecal incontinence; therefore, one must be vigilant in screening for this potentially devastating condition.¹⁸

In case 3, the patient has tried medical therapies for fecal incontinence, including stool-bulking agents and motility regulators such as loperamide hydrochloride. Besides offering fiber supplements (or other stool-bulking agents) or physical therapy, nonsurgical options for this patient are limited.

Newly available: A vaginal insert for fecal incontinence
In 2015, the Eclipse System (Pelvalon) became the first FDA-approved vaginal insert for the treatment of fecal incontinence. The manufacturer recently was granted clearance for its second-generation device (FIGURE 3). The device consists of a silicone-coated stainless steel base with a posteriorly facing balloon and a pressure-regulated pump that allows the patient to control her bowel movements. After a patient is fitted with the device in the office setting, she is independently able to insert and remove it as well as deflate the balloon to allow for bowel movements and inflate the balloon to prevent accidental bowel leakage.

In a multicenter trial conducted by Richter and colleagues,¹⁹ 78% of women successfully fitted with the device had a 50% mean reduction of fecal incontinence episodes. Two-week mean incontinence episodes decreased from 11 to 2 after 1 month of continued use of the insert. In addition, there was significant improvement in quality-of-life questionnaire scores.

Of the 110 patients fitted with the device, 32 (29%) withdrew due to unsatisfactory device fit or were unable to remove or insert the device themselves. Common adverse effects included pelvic cramping and discomfort during device fitting. One month after insertion, pelvic pain and cramping continued in up to 10% of patients. No serious adverse events related to the device were observed during the 1-month trial.¹⁹

In the approximate 70% of women successfully fitted with the vaginal insert, the system was highly efficacious in improving subjective and objective outcomes with no unexpected serious adverse events. Currently the device is available at investigative sites across the United States, and the company plans for sales to begin later this year.

Surgical options for fecal incontinence
In patients for whom conservative and medical therapies have failed, surgical treatments may be offered. Surgical options vary from minimally invasive procedures to colostomy. One of the minimally invasive procedures available is the InterStim procedure, or sacral nerve stimulation (SNS). An electrode is inserted percutaneously through the S3 foramen and is connected to an implanted battery under the skin of the buttocks. Low-voltage stimulation is applied to the leads that lie adjacent to the S3 sacral nerve roots.

Patients with SNS experience fewer episodes of fecal incontinence, with over 80% maintaining a reduction in fecal incontinent episodes by greater than 50% up to 5 years after implantation.^20,21

The transobturator postanal sling system (TOPAS, Astora) is a new investigational surgical device. It is inserted in a minimally invasive procedure and is currently undergoing a prospective, multicenter clinical trial (FIGURE 4). It consists of a polypropylene mesh sling placed perianally, with the mesh arms exiting through the obturator foramen bilaterally. It is intended to increase posterior pelvic support at the level of the anorectal junction. Efficacy and safety of the product have yet to be determined.

We need to stay up to date on new treatment options
As the prevalence increases for urinary and fecal incontinence, ObGyns are challenged to remain knowledgeable about the condition, the prognosis, and the success of interventions. Currently, patients have a range of options to manage their urinary and fecal incontinence symptoms, with the number of products and clinical data increasing over time. With the advent of novel products and the widespread availability of information via the Internet, physicians must remain the established source on new innovative treatments and up-to-date clinical data in order to provide competent and comprehensive care.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Today, “normal” aging is no longer acceptable. From aesthetics to physical, mental, and sexual health, the maturing population seeks effective minimally invasive and practical methods to halt time and reverse its adverse effects. Nowhere is this more apparent than when dealing with urinary and fecal incontinence, conditions that can be not only embarrassing to patients but also debilitating, with potential crippling adverse affects on quality of life. As the US population ages, the prevalence of incontinence is increasing.

Patients commonly present with questions about their incontinence with preconceived notions on their available treatment options based on Internet searches and advertisements from magazines and television. Thus, as gynecologists, we have a pivotal role in educating women on their conditions and management options in a comprehensive, informative, and reassuring manner. By educating patients on the success rates and limitations of available treatments, patients can make informed decisions and reinforce their sense of autonomy. In this article we present the evidence on current, new, and investigative products available for the treatment of both stress urinary incontinence and overactive bladder, as well as fecal incontinence.

Case 1: Stress urinary incontinence
A 46-year-old woman (G2P2) presents with loss of urine with exercise, dancing, and sneezing that began after the birth of her last baby 5 years ago and is progressively becoming more frequent. She performs Kegel exercises occasionally and denies urinary urgency and/or urge incontinence. She reports a 20-lb weight gain in the past 3 years. Physical examination findings reveal normal pelvic examination with adequate pelvic organ support but weakened pelvic floor muscles during contraction. When you ask her to cough, you observe a small amount of urine loss from the urethral meatus. She has heard of “slings” before, but she is anxious about surgery.

Stress urinary incontinence (SUI) is the involuntary loss of urine with effort, physical exertion, sneezing, or coughing.¹ It is the most common type of incontinence in younger women, with risk factors including increasing age, parity, and obesity.^2,3 SUI treatment options, beginning from least to most invasive, include pelvic floor exercises, biofeedback and/or physical therapy, continence devices, off-label use of medications, urethral bulking agents, and surgical correction with slings. Midurethral tension-free slings are highly efficacious for the treatment of SUI. While a sling is a minimally invasive procedure, patients typically voice concerns regarding surgery and appropriately begin with conservative treatments.

A new FDA-approved OTC option for SUI
First-line conservative therapies offered to patients for SUI include pelvic floor muscle exercises and intravaginal continence devices. Disappointingly, such devices—including pessaries and the incontinence dish—have not been popular among patients for SUI. Authors of a randomized control trial evaluating incontinence pessaries versus behavioral therapy, including pelvic floor muscle training, found that, after 3 months, use of a pes‑ sary was not as effective as behavioral therapy in terms of patient satisfaction and improvement in bothersome urinary incontinence.⁴ In our experience, many patients wearing incontinence rings discontinue their use due to ineffectiveness or discomfort.

Patients now have an FDA-approved, over-the-counter option for SUI symptom management. The Poise Impressa is a disposable, nonabsorbent, flexible intravaginal device for patients with SUI (FIGURE 1). The device is comprised of a silicone core with a soft, nonwoven polypropylene fabric cover. It is inserted similar to a tampon, using an applicator, and provides nonobstructive support to the urethra to prevent stress urinary leakage. To find the proper fit, patients purchase the sizing kit, which includes 3 sizes. Patients are to insert size 1 first and monitor their comfort as well as improvement in leakage. Should size 1not sufficiently relieve leakage, the patient may try sizes 2 and 3 successively, with the goal of finding the most comfortable and effective insert. The insert is approved for up to 8 hours of wear in a 24-hour period, at which time the patient removes the device by pulling the string in a similar manner as removing a tampon.

Efficacy and quality of life data. Over 28 days, 85% of women with severe SUI confirmed on urodynamic testing achieved greater than 70% leakage reduction according to measured pad weights.⁵ Seventy percent of women reported 90% improvement in quality of life using validated questionnaires. In addition, 92% reported feeling dry with an improved perception of incontinence and greater confidence during strenuous activities.⁶ There were no serious adverse events, and the most common mild adverse events were discomfort, pain, and spotting.

As more patients become aware of the device through advertising and word of mouth, we expect patients to seek advice from their gynecologists on the safety and efficacy of the insert. In our experience, most patients report improvement in bothersome symptoms with the device and are overall satisfied. For patients who have discomfort with device placement, a water-based lubricant can be used. Patients using vaginal estrogen may apply the medication at night and wear the device during the day.

Office-based bladder control system in the pipeline
For SUI, options are limited for patients who would rather seek office-based procedures than invasive surgeries. Injections of urethral bulking agents can be performed in an office setting by injecting them transurethrally with a cystoscope slightly distal to the bladder neck. While bulking agents have a role in certain patients with SUI, especially those who are not interested in pursuing more invasive surgeries, only 43% have short-term (less than 6 months) cure and 75% report short-term improvement.⁷

A minimally invasive office-based procedure to treat SUI symptoms is under investigation in clinical trials currently. The Vesair Balloon bladder control system (Solace Therapeutics) is performed with cystoscopic guidance and is being tested at multiple sites throughout the United States (FIGURE 2).

The Vesair Balloon acts like a “shock absorber” to reduce momentary increases in bladder pressure due to external forces or stressors. The balloon is a small device, approximately the size of a quarter, and is implanted through the urethra via a specially designed applicator under cystoscopic guidance in the office setting. Pretreatment with pain medication usually is unnecessary. The VesairBalloon may be retained in situ for up to 12 months, at which time it is removed using a device-specific grasper under direct visualization with a cystoscope in the office.

Preliminary efficacy and safety data. In a single-blinded randomized controlled trial, 63% of women in the Vesair Balloon group had significant improvement in provocative pad weights and quality-of-life questionnaire scores at 3 months, compared with 31% in the control group.⁸ No serious adverse events were observed. Eleven of 63 patients (17%) withdrew from the study—most commonly for bladder irritation and dysuria.

We anxiously await the results of a second single-blinded randomized control trial currently being conducted.

Best surgical options for SUI
Today, the standard surgical procedure for SUI is a midurethral sling. Midurethral slings may be placed through 3 routes: retropubic; transobturator; and single-incision, otherwise known as “mini-slings.” Subjective cure rates of retropubic versus transobturator slings are similar, with lower rates of bladder perforation, major vascular/visceral injury, and operative blood loss in the transobturator group.⁹ However, rates of groin pain are higher in the trans‑ obturator group.

Single-incision slings were developed in an effort to avoid the morbidity and pain with passing traditional sling trocars through the obturator space and skin of the groin. In a randomized controlled trial, the Miniarc single- incision sling (Astora Women’s Health) was found to be noninferior to the Monarc transobturator sling (Astora) at 12 and 36 months.¹⁰ There were no statistically significant differences between subjective and objective cure rates on cough stress tests. Postoperative pain and groin pain were significantly less in patients with the Miniarc sling, compared with the Monarc sling.

It is our opinion that as more data become available, single-incision slings will find their foothold in a subset of patients with SUI.

Case 2: Overactive bladder: Failed medication therapy
A healthy 63-year-old woman presents with a 9-month history of loss of urine with strong urges, urinating 4 times per night, and a feeling of urgency when she needs to urinate. She denies pain with urination, difficulty emptying her bladder fully, and pain with a full bladder. She has restricted her fluid intake to 4 glasses of water per day and has stopped drinking fluids 4 hours before bedtime.

She described her symptoms to her intern‑ ist, who prescribed oxybutynin. She took the medication for 3 months but stopped after she developed severe constipation and dry mouth. She states the medication did not help her urinary symptoms. You discuss with her trials of other medications including topical anticholinergics and mirabegron. She is frustrated with her symptoms and asks if there are any other options besides medications.

Overactive bladder (OAB) is present in up to 16% of the US population, with the percentage estimated to increase by 20% within the next 2 years.^11,12 The drastic increase in prevalence, likely due to the aging population, may result in an increased counseling and management burden placed on general practitioners and gynecologists.

First-line management options for OAB are behavioral modifications and/or medications. Our patient in case 2 failed both first-line therapies. When a patient fails or is intolerant to an anticholinergic medication, we offer mirabegron, a beta-3 agonist (after excluding any contraindications to the medication). Beyond medications, the therapeutic options are rather limited.

Second-line OAB treatment options
In January 2013, the FDA expanded the approved use of onabotulinum toxin A (Botox, Allergan) for the treatment of OAB in those who are intolerant of or have failed treatment with anticholinergic medications. Using a cystoscope, 100 units of onabotulinum toxin A are injected into 20 sites within the bladder wall. Due to the risk of urinary retention in up to 6% of patients, it is recommended to administer onabotulinum toxin A to patients who are willing and capable of performing clean intermittent catheterization.¹³

Efficacy data. In a recent systematic review and meta-analysis, the authors concluded onabotulinum toxin A to be effective in the treatment of idiopathic OAB with a statistically significant reduction compared with baseline in the number of incontinence episodes per day (-2.77 in the treatment group vs -1.01 in the placebo group) and the number of voids per day (-1.61 in the treatment group vs -0.87 in the placebo group).¹⁴ Patients who received onabotulinum toxin A experienced a higher rate of adverse effects, such as urinary tract infections, and were more likely to require clean intermittent catheterization due to incomplete bladder emptying.¹³ Patients can expect symptom improvement for approximately 6 months or longer.¹⁵ Based on the manufacturers’ recommendations, patients are not to be reinjected sooner than 12 weeks from prior onabotulinum toxin A injection.

In women with refractory OAB, available second-line treatments include neuromodulation by sacral nerve or posterior tibial nerve stimulation (PTNS). The latter therapy is an office-based procedure that involves placement of a lead percutaneous to the medial aspect of the ankle near the tibial nerve. It is postulated that stimulation of the tibial nerve results in retrograde stimulation of the S3 sacral nerve plexus, resulting in OAB symptom relief in 54% to 70% of patients.¹⁶

Case 3: Fecal incontinence
A 57-year-old, otherwise healthy, multiparous woman presents with a 3-year history of fecal incontinence. She reports that it is embarrassing and distressing. She avoids certain social activities and is not currently sexually active due to the frequency of bowel leakage episodes.

In an effort to decrease her episodes of incontinence, she takes loperamide hydrochloride (Imodium) regularly with little improvement in the frequency of accidents. She has no history of gastrointestinal, rectal, or gynecologic surgery. She had 2 full-term vaginal deliveries that were uncomplicated. On review of systems, she also discloses occasional urinary incontinence.

Physical examination reveals normal vaginal anatomy with adequate pelvic organ support and no neurologic abnormalities. Rectal examination demonstrates normal tone and no evidence of rectal prolapse. Contractions of the pelvic floor muscles are weak. She is frustrated with her condition and seeks your guidance.

Fecal incontinence affects more than 20 million women in the United States, with only one-third of those with the condition disclosing their symptoms to their physician.¹⁷ Many etiologies for accidental bowel leakage exist, with some of the most common being advancing age and obstetric trauma. Up to one-third of women presenting for evaluation of urinary incontinence have fecal incontinence; therefore, one must be vigilant in screening for this potentially devastating condition.¹⁸

In case 3, the patient has tried medical therapies for fecal incontinence, including stool-bulking agents and motility regulators such as loperamide hydrochloride. Besides offering fiber supplements (or other stool-bulking agents) or physical therapy, nonsurgical options for this patient are limited.

Newly available: A vaginal insert for fecal incontinence
In 2015, the Eclipse System (Pelvalon) became the first FDA-approved vaginal insert for the treatment of fecal incontinence. The manufacturer recently was granted clearance for its second-generation device (FIGURE 3). The device consists of a silicone-coated stainless steel base with a posteriorly facing balloon and a pressure-regulated pump that allows the patient to control her bowel movements. After a patient is fitted with the device in the office setting, she is independently able to insert and remove it as well as deflate the balloon to allow for bowel movements and inflate the balloon to prevent accidental bowel leakage.

In a multicenter trial conducted by Richter and colleagues,¹⁹ 78% of women successfully fitted with the device had a 50% mean reduction of fecal incontinence episodes. Two-week mean incontinence episodes decreased from 11 to 2 after 1 month of continued use of the insert. In addition, there was significant improvement in quality-of-life questionnaire scores.

Of the 110 patients fitted with the device, 32 (29%) withdrew due to unsatisfactory device fit or were unable to remove or insert the device themselves. Common adverse effects included pelvic cramping and discomfort during device fitting. One month after insertion, pelvic pain and cramping continued in up to 10% of patients. No serious adverse events related to the device were observed during the 1-month trial.¹⁹

In the approximate 70% of women successfully fitted with the vaginal insert, the system was highly efficacious in improving subjective and objective outcomes with no unexpected serious adverse events. Currently the device is available at investigative sites across the United States, and the company plans for sales to begin later this year.

Surgical options for fecal incontinence
In patients for whom conservative and medical therapies have failed, surgical treatments may be offered. Surgical options vary from minimally invasive procedures to colostomy. One of the minimally invasive procedures available is the InterStim procedure, or sacral nerve stimulation (SNS). An electrode is inserted percutaneously through the S3 foramen and is connected to an implanted battery under the skin of the buttocks. Low-voltage stimulation is applied to the leads that lie adjacent to the S3 sacral nerve roots.

Patients with SNS experience fewer episodes of fecal incontinence, with over 80% maintaining a reduction in fecal incontinent episodes by greater than 50% up to 5 years after implantation.^20,21

The transobturator postanal sling system (TOPAS, Astora) is a new investigational surgical device. It is inserted in a minimally invasive procedure and is currently undergoing a prospective, multicenter clinical trial (FIGURE 4). It consists of a polypropylene mesh sling placed perianally, with the mesh arms exiting through the obturator foramen bilaterally. It is intended to increase posterior pelvic support at the level of the anorectal junction. Efficacy and safety of the product have yet to be determined.

We need to stay up to date on new treatment options
As the prevalence increases for urinary and fecal incontinence, ObGyns are challenged to remain knowledgeable about the condition, the prognosis, and the success of interventions. Currently, patients have a range of options to manage their urinary and fecal incontinence symptoms, with the number of products and clinical data increasing over time. With the advent of novel products and the widespread availability of information via the Internet, physicians must remain the established source on new innovative treatments and up-to-date clinical data in order to provide competent and comprehensive care.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Applications are now open for...

Every Heartbeat Matters Valve Disease Fellowship

Applications for the second award cycle of the Every Heartbeat Matters Valve Fellowship — a joint project of the AATS Graham and Edwards Lifesciences Foundation — are now open. The mission of Every Heartbeat Matters is to impact the global burden of heart valve disease by serving one million people by 2020.

The fellowship’s goal is to enhance the knowledge and skills of practicing cardiothoracic surgeons who are already treating or committed to treating underserved patients worldwide. It provides up to three months of advanced heart valve disease training and education at a host institution.

More information/application
Deadline: February 15, 2016

2016 Graham Surgical Investigator Program

The Graham Surgical Investigator Program supports innovative clinical or translational research for young cardiothoracic surgeons. Topics include, but are not limited to, topics related to outcomes research, as well as robotically assisted surgery, minimally invasive surgery or other applications of new and innovative technologies in cardiothoracic surgery.

Up to four proposals will be funded in 2016.

Thanks to the generosity of Ethicon, Intuitive Surgical, Dr. Mehmet Oz and AATS.

More information/application
Deadline: February 15, 2016

Applications are now open for...

Every Heartbeat Matters Valve Disease Fellowship

Applications for the second award cycle of the Every Heartbeat Matters Valve Fellowship — a joint project of the AATS Graham and Edwards Lifesciences Foundation — are now open. The mission of Every Heartbeat Matters is to impact the global burden of heart valve disease by serving one million people by 2020.

The fellowship’s goal is to enhance the knowledge and skills of practicing cardiothoracic surgeons who are already treating or committed to treating underserved patients worldwide. It provides up to three months of advanced heart valve disease training and education at a host institution.

More information/application
Deadline: February 15, 2016

2016 Graham Surgical Investigator Program

The Graham Surgical Investigator Program supports innovative clinical or translational research for young cardiothoracic surgeons. Topics include, but are not limited to, topics related to outcomes research, as well as robotically assisted surgery, minimally invasive surgery or other applications of new and innovative technologies in cardiothoracic surgery.

Up to four proposals will be funded in 2016.

Thanks to the generosity of Ethicon, Intuitive Surgical, Dr. Mehmet Oz and AATS.

More information/application
Deadline: February 15, 2016

Applications are now open for...

Every Heartbeat Matters Valve Disease Fellowship

Applications for the second award cycle of the Every Heartbeat Matters Valve Fellowship — a joint project of the AATS Graham and Edwards Lifesciences Foundation — are now open. The mission of Every Heartbeat Matters is to impact the global burden of heart valve disease by serving one million people by 2020.

The fellowship’s goal is to enhance the knowledge and skills of practicing cardiothoracic surgeons who are already treating or committed to treating underserved patients worldwide. It provides up to three months of advanced heart valve disease training and education at a host institution.

More information/application
Deadline: February 15, 2016

2016 Graham Surgical Investigator Program

The Graham Surgical Investigator Program supports innovative clinical or translational research for young cardiothoracic surgeons. Topics include, but are not limited to, topics related to outcomes research, as well as robotically assisted surgery, minimally invasive surgery or other applications of new and innovative technologies in cardiothoracic surgery.

Up to four proposals will be funded in 2016.

Thanks to the generosity of Ethicon, Intuitive Surgical, Dr. Mehmet Oz and AATS.

More information/application
Deadline: February 15, 2016

June 24-25, 2016
Renaissance Boston Waterfront Hotel
Boston, MA

Co-Directors
Thoralf M. Sundt, III, MD
Steven Yule, PhD

Program Committee
David J. Bunnell, PA-C, APACVS
David C. Fitzgerald, CCP, AMSECT
Jake Jaquiss, MD
M. Blair Marshall, MD
Shannon Pengel, RN
Kenneth Shann, CCP, LP, AMSECT
Marco Zenati, MD

Improving patient care remains a constant mission for all members of the surgical team. The AATS Surgical Patient Safety Course has been designed to promote a culture of safety and reduce preventable patient harm by engaging, educating, and equipping members of the cardiothoracic surgical team in the multidimensional approach to patient safety.

The course — which features didactic and interactive presentations and focused workshops — will provide attendees with essential patient safety knowledge, skills, and attitudes aimed at improving care in the present and future.

Preliminary Program Now Online

The Patient Safety program includes team training and simulaltion experiences.

Surgical Team Registration
Register three or more members from the same institution and receive one complimentary Healthcare Professional registration. We encourage you to send the entire team to Boston this June for this important course.

Register Your Team Before May 23, 2016 & Save

June 24-25, 2016
Renaissance Boston Waterfront Hotel
Boston, MA

Co-Directors
Thoralf M. Sundt, III, MD
Steven Yule, PhD

Program Committee
David J. Bunnell, PA-C, APACVS
David C. Fitzgerald, CCP, AMSECT
Jake Jaquiss, MD
M. Blair Marshall, MD
Shannon Pengel, RN
Kenneth Shann, CCP, LP, AMSECT
Marco Zenati, MD

Improving patient care remains a constant mission for all members of the surgical team. The AATS Surgical Patient Safety Course has been designed to promote a culture of safety and reduce preventable patient harm by engaging, educating, and equipping members of the cardiothoracic surgical team in the multidimensional approach to patient safety.

The course — which features didactic and interactive presentations and focused workshops — will provide attendees with essential patient safety knowledge, skills, and attitudes aimed at improving care in the present and future.

Preliminary Program Now Online

The Patient Safety program includes team training and simulaltion experiences.

Surgical Team Registration
Register three or more members from the same institution and receive one complimentary Healthcare Professional registration. We encourage you to send the entire team to Boston this June for this important course.

Register Your Team Before May 23, 2016 & Save

June 24-25, 2016
Renaissance Boston Waterfront Hotel
Boston, MA

Co-Directors
Thoralf M. Sundt, III, MD
Steven Yule, PhD

Program Committee
David J. Bunnell, PA-C, APACVS
David C. Fitzgerald, CCP, AMSECT
Jake Jaquiss, MD
M. Blair Marshall, MD
Shannon Pengel, RN
Kenneth Shann, CCP, LP, AMSECT
Marco Zenati, MD

Improving patient care remains a constant mission for all members of the surgical team. The AATS Surgical Patient Safety Course has been designed to promote a culture of safety and reduce preventable patient harm by engaging, educating, and equipping members of the cardiothoracic surgical team in the multidimensional approach to patient safety.

The course — which features didactic and interactive presentations and focused workshops — will provide attendees with essential patient safety knowledge, skills, and attitudes aimed at improving care in the present and future.

Preliminary Program Now Online

The Patient Safety program includes team training and simulaltion experiences.

Surgical Team Registration
Register three or more members from the same institution and receive one complimentary Healthcare Professional registration. We encourage you to send the entire team to Boston this June for this important course.

Register Your Team Before May 23, 2016 & Save