A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months.

INTRODUCTION AND HYPOTHESIS: There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. METHODS: Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months' follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. RESULTS: A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (-21.1 ± 24.5 vs -14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57). CONCLUSIONS: Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.

Impact of surgical training on the performance of proposed quality measures for hysterectomy for pelvic organ prolapse.

BACKGROUND: Recent healthcare reform has led to increased emphasis on standardized provision of quality care. Use of government- and organization-approved quality measures is 1 way to document quality care. Quality measures, to improve care and aid in reimbursement, are being proposed and vetted in many areas of medicine. OBJECTIVES: We aimed to assess performance of proposed quality measures that pertain to hysterectomy for pelvic organ prolapse stratified by surgical training. The 4 quality measures that we assessed were (1) the documentation of offering conservative treatment of pelvic organ prolapse, (2) the quantitative assessment of pelvic organ prolapse (Pelvic Organ Prolapse-Quantification or Baden-Walker), (3) the performance of an apical support procedure, and (4) the performance of cystoscopy at time of hysterectomy. STUDY DESIGN: Patients who underwent hysterectomy for pelvic organ prolapse from January 1 to December 31, 2008, within a large healthcare maintenance organization were identified by diagnostic and procedural codes within the electronic medical record. Medical records were reviewed extensively for demographic and clinical data that included the performance of the 4 proposed quality measures and the training background of the primary surgeon (gynecologic generalist, fellowship-trained surgeon in Female Pelvic Medicine and Reconstructive Surgery, and "grandfathered" Female Pelvic Medicine and Reconstructive Surgery). Data were analyzed with the use of descriptive statistics. Inferential statistics with chi-squared tests were used to compare performance rates of quality measures that were stratified by surgical training. Probability values <.05 were considered statistically significant. RESULTS: Six hundred thirty patients who underwent hysterectomy for pelvic organ prolapse in 2008 had complete records available for analysis. Fellowship-trained surgeons performed 302 hysterectomies for pelvic organ prolapse; grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed 98 hysterectomies, and gynecologic generalist surgeons performed 230 hysterectomies. Fellowship-trained surgeons had the highest performance rates for individual quality measures (91.4-98.7%) and cumulative performance of all measures (80.8% of cases). Grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed significantly fewer measures (80.6-95.9% performance rate for individual measures; 65.3% cumulatively for all measures) than fellowship-trained surgeons and more than gynecologic generalists (64.3-70% for individual measures; 29.1% cumulatively for all measures). There was an association between surgeon training background and number of hysterectomies performed for pelvic organ prolapse, with specialist surgeons performing more hysterectomies. When quality measure performance was stratified by surgeon volume, similar significant associations were found, with high-volume surgeons performing more quality measures than low-volume surgeons. CONCLUSION: Within a large healthcare maintenance organization, fellowship-trained Female Pelvic Medicine and Reconstructive Surgery surgeons were more likely to perform proposed quality measures in women who underwent hysterectomy for pelvic organ prolapse compared with those surgeons without such training. Grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed measures more frequently than gynecologic generalists but less than fellowship-trained surgeons. Further study is indicated to correlate the proposed quality measures with clinical outcomes.

Risk Factors for De Novo Overactive Bladder After Midurethral Sling.

IMPORTANCE: The low incidence of de novo overactive bladder (OAB) symptoms after a midurethral sling (MUS) procedure better informs preoperative counseling. OBJECTIVE: The study aimed to measure the incidence and risk factors for de novo OAB after MUS. STUDY DESIGN: This was a retrospective cohort study of de novo OAB symptoms in patients who underwent MUS surgery in a health maintenance organization between January 1, 2008, and September 30, 2016. Patients were identified using Current Procedural Terminology codes for MUS and International Classification of Diseases, Tenth Revision codes for urinary urgency, frequency, nocturia, OAB, and urgency urinary incontinence (UUI). The cohort of patients was identified by the absence of these International Classification of Diseases, Tenth Revision codes 12 months preoperatively and the presence of these codes within 6 months after surgery. This cohort was used to calculate the rate of de novo OAB after MUS surgery. Clinical and demographic factors were abstracted. Statistical analysis was performed using descriptive, χ2 , simple logistic, and multiple logistic regression. RESULTS: During the study period, 13,893 patients underwent MUS surgery and 6,634 met the inclusion criteria. The mean age was 56.9 years, mean parity was 2.76, and mean body mass index was 28.9 (calculated as weight in kilograms divided by height in meters squared). Of these, 410 (6.1%) developed de novo OAB within 12 months. The most common symptoms were urgency (65.4%), UUI (42.2%), and frequency (19.8%). On multivariable regression modeling, de novo urgency and UUI were not associated with concurrent surgery ( P < 0.05). Increasing age and body mass index were associated with an increased risk of nocturia ( P < 0.05). CONCLUSIONS: The incidence of de novo OAB after MUS surgery was 6.1%. This aligns with current literature and critically informs preoperative counseling for MUS surgery.

Digital Therapeutic Device for Urinary Incontinence: A Longitudinal Analysis at 6 and 12 Months.

OBJECTIVE: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). METHODS: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with "much better" and "very much better" responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and χ2 tests as appropriate. RESULTS: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9±12.8 years, and mean body mass index (BMI) was 31.8±7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2±20.9 vs 14.8±19.5, P=.03 and 22.7±23.3 vs 15.9±20.3, P=.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49-4.00). CONCLUSION: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care. FUNDING SOURCE: Renovia Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153.

Retreatment of Stress Urinary Incontinence After Midurethral Sling With Prior Urethral Bulking.

IMPORTANCE: There is limited current literature regarding the retreatment of stress urinary incontinence (SUI) after midurethral sling (MUS) placement with prior urethral bulking. OBJECTIVE: The objective was to evaluate the retreatment and perioperative complications of MUS placement with prior urethral bulking compared with MUS placement without prior urethral bulking. STUDY DESIGN: This was a retrospective cohort study of patients within the Southern California Permanente Medical Group who underwent MUS placement from January 2009 to December 2020. Patients who underwent prior urethral bulking were compared with a control group without prior urethral bulking in a 1:1 ratio matched by age and MUS procedure date. The primary outcome was the retreatment of SUI after MUS placement with prior urethral bulking. Secondary outcomes were perioperative complications. Regression models were used to evaluate associations between retreatment and perioperative complications while controlling for confounding variables. RESULTS: Eighty-five patients who underwent MUS placement with prior urethral bulking were identified and matched with 85 control patients who underwent MUS placement without prior urethral bulking. Patients who underwent MUS placement without prior urethral bulking were more likely to have concomitant surgery. Linear regression analysis controlling for the effect of concomitant surgery revealed no difference in estimated blood loss and operative time between the 2 groups. In logistic regression analysis, there was no difference in the retreatment rate and perioperative complications between groups. CONCLUSION: We found that the unique treatment combination of MUS placement with prior urethral bulking for recurrent SUI seems to have a similar retreatment rate and perioperative complications as MUS placement without prior urethral bulking.

Rectocele: Correlation Between Defecography and Physical Examination.

IMPORTANCE: There is a lack of consensus regarding the clinical applicability of fluoroscopic defecography in evaluation of pelvic organ prolapse. OBJECTIVES: The aim was to evaluate the association between rectocele on defecography and posterior vaginal wall prolapse (PVWP) on physical examination. The secondary objective was to describe radiologic and clinical predictors of surgical intervention and outcomes. STUDY DESIGN: This was a retrospective review of patients enrolled in a large health maintenance organization who underwent defecography and were examined by a urogynecologist within 12 months. The electronic medical record was reviewed for demographic and clinical variables, including pelvic organ prolapse and defecatory symptoms, physical examination, and surgical intervention through 12 months after initial urogynecologic examination or 12 months after surgery if applicable. RESULTS: One hundred eighty-six patients met inclusion criteria. Of those, 168 (90.3%) had a rectocele on defecography and 31 (16.6%) had PVWP at or beyond the hymen. Rectocele size on defecography was poorly correlated with PVWP stage (spearman ρ = 0.18). Forty patients underwent surgical intervention. Symptoms of splinting, digitation, and stool trapping were associated with surgical intervention (odds ratio, 4.24; 95% confidence interval, 1.59-11.34; P < 0.01) as was advanced PVWP stage ( P < 0.01), while rectocele presence and size on defecography were not. Large rectocele size on defecography was correlated with persistent postoperative defecatory symptoms ( P = 0.02). CONCLUSIONS: We demonstrated a poor correlation between rectocele size on defecography and PVWP stage. Defecatory symptoms (splinting, digitation, stool trapping) and higher PVWP stage were associated with surgical intervention, while rectocele on defecography was not.

Performance of Perioperative Tasks for Women Undergoing Anti-incontinence Surgery: Developed by the AUGS Quality Improvement and Outcomes Research Network.

OBJECTIVES: Surgery for the correction of stress urinary incontinence is an elective procedure that can have a dramatic and positive impact on quality of life. Anti-incontinence procedures, like inguinal hernia repairs or cholecystectomies, can be classified as high-volume/low-morbidity procedures. The performance of a standard set of perioperative tasks has been suggested as one way to optimize quality of care in elective high-volume/low-morbidity procedures. Our primary objective was to evaluate the performance of 5 perioperative tasks-(1) offering nonsurgical treatment, (2) performance of a standard preoperative prolapse examination, (3) cough stress test, (4) postvoid residual test, and (5) intraoperative cystoscopy for women undergoing surgery for stress urinary incontinence-compared among surgeons with and without board certification in female pelvic medicine and reconstructive surgery (FPMRS). STUDY DESIGN: This study was a retrospective chart review of anti-incontinence surgical procedures performed between 2011 and 2013 at 9 health systems. Cases were reviewed for surgical volume, adverse outcomes, and the performance of 5 perioperative tasks and compared between surgeons with and without FPMRS certification. RESULTS: Non-FPMRS surgeons performed fewer anti-incontinence procedures than FPMRS-certified surgeons. Female pelvic medicine and reconstructive surgery surgeons were more likely to perform all 5 perioperative tasks compared with non-FPMRS surgeons. After propensity matching, FPMRS surgeons had fewer patients readmitted within 30 days of surgery compared with non-FPMRS surgeons. CONCLUSIONS: Female pelvic medicine and reconstructive surgery surgeons performed higher volumes of anti-incontinence procedures, were more likely to document the performance of the 5 perioperative tasks, and were less likely to have their patients readmitted within 30 days.

Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI). METHODS: In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting. RESULTS: From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3-8) and 5 (3-8) episodes to 1 (0-3) and 2 (1-4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21-3.15). There were no device-related severe adverse events. CONCLUSION: In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153. FUNDING SOURCE: Renovia Inc.

Prevalence and Nature of Sexist and Racial/Ethnic Microaggressions Against Surgeons and Anesthesiologists.

Importance: Workplace mistreatment can manifest as microaggressions that cause chronic, severe distress. As physician burnout becomes a global crisis, quantitative research to delineate the impact of microaggressions is imperative. Objectives: To examine the prevalence and nature of sexist and racial/ethnic microaggressions against female and racial/ethnic-minority surgeons and anesthesiologists and assess the association with physician burnout. Design, Setting, and Participants: This cross-sectional survey evaluated microaggressions and physician burnout within a diverse cohort of surgeons and anesthesiologists in a large health maintenance organization. A total of 1643 eligible participants were sent a recruitment email on January 8, 2020, 1609 received the email, and 652 replied, for a response rate of 41%. The study survey remained open until February 20, 2020. A total of 588 individuals (37%) were included in the study after exclusion criteria were applied. Exposures: The Maslach Burnout Inventory, the Racial Microaggression Scale, and the Sexist Microaggression Experience and Stress Scale. Main Outcomes and Measures: The primary outcomes were prevalence and nature of sexist and racial/ethnic microaggressions against female and racial/ethnic-minority surgeons and anesthesiologists using the Sexist Microaggression Experience and Stress Scale and Racial Microaggression Scale. Secondary outcomes were frequency and severity of microaggressions, prevalence of physician burnout, and associations between microaggressions and physician burnout. Results: Data obtained from 588 respondents (249 [44%] female, 367 [62%] racial/ethnic minority, 224 [38.1%] 40-49 years of age) were analyzed. A total of 245 of 259 female respondents (94%) experienced sexist microaggressions, most commonly overhearing or seeing degrading female terms or images. Racial/ethnic microaggressions were experienced by 299 of 367 racial/ethnic-minority physicians (81%), most commonly reporting few leaders or coworkers of the same race/ethnicity. Criminality was rare (18 of 367 [5%]) but unique to and significantly higher for Hispanic and Black physicians. Individuals who identified as underrepresented minorities were more likely to experience environmental inequities (odds ratio [OR], 4.21; 95% CI, 1.6-10.75; P = .002) and criminality (OR, 14.93; 95% CI, 4.5-48.5; P < .001). The prevalence of physician burnout was 47% (280 of 588 physicians) and higher among female physicians (OR, 1.60; 95% CI, 1.03-2.47; P = .04) and racial/ethnic-minority physicians (OR, 2.08; 95% CI, 1.31-3.30; P = .002). Female physicians who experienced sexist microaggressions (racial/ethnic-minority female physicians: OR, 1.84; 95% CI, 1.04-3.25; P = .04; White female physicians: OR, 1.99; 95% CI, 1.07-3.69; P = .03) were more likely to experience burnout. Racial/ethnic-minority female physicians (OR, 1.86; 95% CI, 1.03-3.35; P = .04) who experienced racial microaggressions were more likely to report burnout. Racial/ethnic-minority female physicians who had the compound experience of sexist and racial/ethnic microaggressions (OR, 2.05; 95% CI, 1.14-3.69; P = .02) were more likely to experience burnout. Conclusions and Relevance: The prevalence of sexist and racial/ethnic microaggressions against female and racial/ethnic-minority surgeons and anesthesiologists was high and associated with physician burnout. This study provides a valuable response to the increasing call for evidence-based data on surgical workplace mistreatment.

Bowel Obstruction After Sacrocolpopexy: A Case Series.

OBJECTIVES: Bowel obstruction after sacrocolpopexy (SC) can cause significant morbidity. The aim of this study was to delineate clinical and surgical factors associated with bowel obstruction after SC and to describe its presentation, management, and sequelae. METHODS: We performed a retrospective case series of patients who underwent open, laparoscopic, or robotic SC within a large health maintenance organization and a single academic medical center between January 1, 2009, and December 31, 2019. RESULTS: Of 3,231 patients who underwent SC, 32 (1.0%) experienced a bowel obstruction. Sacrocolpopexy was performed laparoscopically or robotically in 19 (59.4%) and abdominally in 13 (40.6%). The mean time to bowel obstruction was 1.9 years (SD, 2.5; range, 3 days to 8.8 years). In patients who experienced bowel obstruction, medical management was undertaken in 19 (61.3%) cases. Eight of the 13 (61.5%) surgically managed cases underwent bowel resection, and 3 cases (23.1%) reported partial mesh excision. Recurrent obstruction was seen in 2 (10.5%) of the medically managed and 2 (15.4%) of the surgically managed cases. CONCLUSIONS: Bowel obstruction is a rare complication of SC and our rate of at least 1.0% corroborates those in the literature. Obstruction occurs from days to years after SC. Nonsurgical management was effective in most cases, with low rates of recurrent obstruction. In surgically managed cases, the majority included bowel resection or mesh excision; however, mesh excision was not associated with a subsequent identifiable procedural intervention for recurrent prolapse. These data inform patient counseling and surgical planning before SC and aid in diagnosis and management of bowel obstruction after SC.

Evidence for the innervation of pelvic floor muscles by the pudendal nerve.

OBJECTIVE: To evaluate whether the pudendal nerve innervates the levator ani muscles by assessing the effect of pudendal nerve blockade on pelvic floor muscle function. METHODS: Eleven nulliparous women without symptoms of anal or urinary incontinence were studied before and after pudendal nerve blockade with vaginal manometry, electromyography of the external anal sphincter and puborectalis muscle, and 3-dimensional transperineal ultrasound imaging of the urogenital hiatus during rest and squeeze. RESULTS: After pudendal nerve blockade, mean vaginal resting pressures decreased from 19 +/- 10 mm Hg to 15 +/- 10 mm Hg (P < .05), and mean vaginal squeeze pressures decreased from 61 +/- 29 mm Hg to 37 +/- 24 mm Hg (P < .05). After pudendal nerve blockade, the anterior-posterior length of the urogenital hiatus increased from 51 +/- 4 mm to 55 +/- 5 mm at rest (P < .05) and increased from 47 +/- 3 mm to 52 +/- 5 mm during squeeze (P < .05). Resting and squeeze electromyography amplitude of the external anal sphincter and puborectalis muscle was markedly reduced by pudendal nerve blockade. CONCLUSION: Pudendal nerve blockade decreases vaginal pressures, increases length of urogenital hiatus, and decreases electromyography activity of the puborectalis muscle, all of which suggest that the pudendal nerve does innervate the levator ani muscle.

The vaginal pressure profile.

AIMS: To describe the vaginal pressure profile in asymptomatic nulliparous women. METHODS: Fourteen nulliparous women without symptoms of anal or urinary incontinence were studied with vaginal manometry. A rapid pull-through technique utilized a four-channel water-perfused catheter on a motor-driven puller to create a pressure profile for each subject. The profiles were measured with the subject at rest and during a sustained contraction of the levator ani muscle. The individual subject's pressure profiles were averaged to create a composite profile at rest and during squeeze. RESULTS: The vaginal pressure profile at rest and during squeeze contains three pressure zones: proximal, mid, and distal. The pressure is highest in the mid pressure zone and was labeled as the vaginal high-pressure zone. In the vaginal high-pressure zone, the maximum pressure during squeeze is significantly higher than the maximum pressure at rest (P < 0.05). The length of the high-pressure zone is longer during squeeze as compared to rest (P < 0.05). The maximum pressures exhibit circumferential asymmetry with the pressures in anterior and posterior directions being significantly higher than those in the lateral directions (P < 0.05). CONCLUSIONS: The vaginal pressure profile is more complex than previously described. Understanding of the vaginal pressure profile is crucial when employing vaginal manometry to assess pelvic floor muscle strength or as a surrogate for intra-abdominal pressure.