Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.

IMPORTANCE: Mixed urinary incontinence (MUI) is common and can be challenging to manage. OBJECTIVES: We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A ( MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component). STUDY DESIGN: The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness. RESULTS: Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase. CONCLUSIONS: This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.

Effect of Second-Stage Pushing Timing on Postpartum Pelvic Floor Morbidity: A Randomized Controlled Trial.

OBJECTIVE: To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity. METHODS: This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1-5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP). RESULTS: Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P =.01), but less than the minimum important difference of 4. CONCLUSION: Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02137200.

Development of a patient-centered text message-based platform for the self-management of interstitial cystitis/bladder pain syndrome symptoms.

OBJECTIVE: To develop a patient-centered text message-based platform that promotes self-management of symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: Adult women with IC/BPS interested in initiating a first- or second-line treatments per American Urological Association guidelines (recategorized as "behavioral/non-pharmacologic treatments" and "oral medicines" in the 2022 version) participated in rapid cycle innovation consisting of iterative cycles of contextual inquiry, prototype design and development. We delivered treatment modules and supportive messages using an algorithm-driven interactive messaging prototype through a HIPAA-compliant texting platform. Patients provided feedback through narrative text messages and an exit interview. Feedback was analyzed qualitatively and used to iteratively revise the platform until engagement ≥ 85% and accuracy ≥ 80% were achieved. The final version consisted of four treatment module categories (patient education and behavioral modification, cognitive behavioral therapy, pelvic floor physical therapy, and guided mindfulness practices) and supportive messages delivered through an automated algorithm over 6 weeks. RESULTS: Thirty IC/BPS patients with moderate symptom bother (median IC Problem Index score 9, range 6-12) participated in five cycles of contextual inquiry. Qualitative analysis identified three overarching concepts that informed the development of the platform: preference for patient centered terms, desire to gain self-efficacy in managing symptoms, and need for provider support. Patients preferred the term "interstitial cystitis" to "bladder pain syndrome" which carried the stigma of chronic pain. Patients reported greater self-efficacy in managing symptoms through improved access to mind-body and behavioral treatment modules that helped them to gain insight into their motivations and behaviors. The concept of provider support was informed by shared decision making (patients could choose preferred treatment modules) and reduced sense of isolation (weekly check in messages to check on symptom bother). CONCLUSION: A patient centered text message-based platform may be clinically useful in the self-management of IC/BPS symptoms.

Is the volume of Burch urethropexy sufficient for urogynecology fellows to meet the ACGME requirement?

INTRODUCTION AND HYPOTHESIS: Urogynecology fellows report low exposure to nonsling retropubic anti-incontinence procedures such as Burch urethropexy and thus may have difficulty meeting the required minimum case numbers, but there has been an even more objective exploration of this observation. Thus, our objective was to assess the feasibility of meeting the Accreditation Council for Graduate Medical Education (ACGME) requirement for each urogynecology fellow to perform five nonsling retropubic anti-incontinence procedures during fellowship. METHODS: Cross-sectional study using the National Surgical Quality Improvement Program (NSQIP) and National Resident Matching Program (NRMP) databases from 2009 to 2019. From NSQIP, the number of nonsling retropubic anti-incontinence procedures (open and laparoscopic Burch urethropexy and bladder neck needle suspension) and midurethral sling procedures was extracted using CPT codes. The number of fellows was extracted from the NRMP database. Trends in the number of anti-incontinence procedures were compared with the trend in the number of fellows using linear regression. RESULTS: From 2009 to 2019 the number of fellows doubled from 81 to 176. An average of 97 nonsling retropubic anti-incontinence and 6,372 sling procedures were performed annually. Linear regression showed an increase of 10.7 fellows per year (95% CI 9.3-12.1) versus an increase of 5.8 nonsling retropubic anti-incontinence procedures per year (95% CI -0.4 to 12.1). This contrasts with an increase of 690.9 slings per year (95% CI 509.9-872.0). CONCLUSIONS: The increase in the number of nonsling retropubic anti-incontinence procedures does not appear to match the increase in the number of urogynecology fellows. Supplementary educational approaches such as simulation may be prudent.

Reducing Falls in Older Women with Urinary Incontinence.

Urinary incontinence is common in older women and doubles the risk of falls in this population. The association between urinary incontinence, especially urgency urinary incontinence, and falls is multifactorial and likely the result of a complex interaction between physical, mental, social, and environmental factors. As a result of this multifactorial etiology and based on existing evidence, the integration of different fall prevention strategies including strength and resistance exercises, bladder training, and home hazard reduction have the potential to decrease the risk of falls in older women with urinary incontinence. Given the prevalence of urinary incontinence and the significant morbidity associated with falls, effective interventions to reduce fall risk in older women with urinary incontinence is of high public health significance.

Relationship Between Opioid Prescriptions and Number of Chronic Pain Conditions in Women With Interstitial Cystitis.

OBJECTIVES: The aim of this study was to determine the relationship between opioid prescriptions and number of chronic pain conditions in women with interstitial cystitis (IC). METHODS: This was a cross-sectional study. Women diagnosed with IC based on International Classification of Diseases, Ninth Revision/Tenth Revision codes over an 11-year period (2010-2020) were identified from electronic medical records. Data on comorbidities and ambulatory opioid prescriptions were also extracted. Univariable and multivariable logistic regressions were used to assess the relationship between opioid prescriptions and the number and type of coexisting chronic pain conditions. RESULTS: Of the 1,219 women with IC, 207 (17%) had received at least 1 opioid prescription. The proportions of women with opioid prescriptions for no, 1, 2, and 3 or more coexisting chronic pain conditions were 13%, 20%, 28%, and 32%, respectively. On univariable analysis, factors significantly associated with opioid use were higher body mass index ( P < 0.001), depression ( P < 0.001), sleep disorder ( P < 0.001), endometriosis ( P < 0.05), chronic pelvic pain ( P < 0.001), fibromyalgia ( P < 0.05), joint pain ( P < 0.001), and number of coexisting chronic pain diagnoses ( P < 0.001). On multivariable analysis, opioid prescriptions remained significantly associated with the number of coexisting chronic pain diagnoses: 1 diagnosis (adjusted odds ratio [aOR], 1.8; 95% confidence interval [CI], 1.3-2.7), 2 diagnoses (aOR, 2.6; 95% CI, 1.6-4.3), 3 or more diagnoses (aOR, 2.5; 95% CI, 1.1-5.5), diagnosis of chronic pelvic pain (aOR, 2.1; 95% CI, 1.3-3.5), endometriosis (aOR, 2.4; 95% CI, 1.4-4.3), chronic joint pain (aOR, 1.8; 95% CI, 1.1-2.9), and sleep disorders (aOR, 2.4; 95% CI, 1.6-3.6). CONCLUSION: The likelihood of opioid prescriptions in women with IC increases with the number and type of coexisting chronic pain conditions and sleep disorders.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

INTRODUCTION: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS: Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Short-Term Effect of Fesoterodine on Physical Function Relevant to Fall Risk in Older Women With Overactive Bladder.

PURPOSE: The aim of this study was to measure the effect of treatment with fesoterodine on physical function relevant to fall risk in older women with overactive bladder. MATERIALS AND METHODS: This was a prospective cohort study of women aged 65 years or older with overactive bladder. Urinary symptoms and physical function were measured at baseline and 8 weeks after treatment with fesoterodine. Physical activity and sedentary behavior were measured subjectively using questionnaires and objectively using an accelerometer. Physical function was measured using the Short Physical Performance Battery test. RESULTS: We enrolled 75 women with a median age of 76 years. At baseline, bothersome urgency urinary incontinence and nocturia were reported by 55% and 81%, respectively. At baseline, participants were highly sedentary with a median of 2,118 steps daily. After treatment, urinary symptom severity and health-related quality of life subscale scores of the Overactive Bladder Questionnaire improved significantly (-22.3±24 and 17.5±19.7, respectively; P < 0.0001). The proportion of participants who self-reported a moderate-to-high level of physical activity increased from 27% to 35% after treatment (P = 0.86). However, daily steps decreased significantly (-420.2±949, P < 0.001), whereas daily sedentary time increased by 36.6±88 minutes (P < 0.001). There was no significant change in the Short Physical Performance Battery score (-0.3±2.3, P = 0.6). CONCLUSIONS: In older women with overactive bladder, short-term treatment with fesoterodine decreased objectively measured physical activity with no significant change in physical function. Treatment with anticholinergics may need to be supplemented with other therapies to address fall risk in older women with overactive bladder.

Pilot randomized controlled trial of a hypnosis intervention for women with bladder pain syndrome.

AIMS: To evaluate the feasibility and acceptability of a randomized controlled trial of a hypnosis intervention for the treatment of bladder pain syndrome/interstitial cystitis (BPS/IC) in women. METHODS: We conducted a parallel arm, non-blinded, pilot randomized controlled trial of standardized hypnosis sessions including a hypnosis web tool versus usual care in adult women with BPS/IC. Pilot study outcomes included feasibility domains: process, resources and management, safety, and acceptability. Clinical outcomes of lower urinary tract symptoms and quality of life were measured using validated questionnaires at baseline and at the end of the 4-week intervention. RESULTS: We randomized 29 out of 30 (96.7%) eligible women. In the hypnosis group, 12 of 15 (80.0%) subjects completed the 4-week intervention and follow up, and 13 of 14 (92.9%) in the usual care group. In the hypnosis group, adherence to the standardized sessions was 80% and participants used the web-based tool for an average of 5.6 ± 2.7 times per week. Scores for emotional distress, relaxation, pain severity and expected bladder symptoms significantly improved during the first two of three planned hypnosis sessions (all p < 0.05). Improvement in quality of life scores was greater in the hypnosis group than the usual care group (-2.6 ± 2.3 vs. -0.9 ± 1.1, p = 0.04). There were no significant between-group differences in urinary symptoms or bladder pain. No adverse events were reported. CONCLUSIONS: A hypnosis intervention for the treatment of bladder pain syndrome/interstitial cystitis is feasible, acceptable, safe, and may improve quality of life.

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

OBJECTIVES: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage. METHODS: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

Is Nocturia Associated With Detrusor Underactivity?

OBJECTIVES: Detrusor underactivity (DU) is diagnosed using urodynamic testing. We hypothesized that nocturia is associated with detrusor underactivity. METHODS: We performed a retrospective chart review of all women who underwent urodynamic testing at our institution between 2016 and 2018. Uroflowmetry and pressure-flow study parameters were compared between women with nocturia (≥2 voids/night) and without nocturia (0-1 void/night). Detrusor underactivity was diagnosed using 3 different criteria: (1) bladder voiding efficiency (BVE) of <90%, (2) bladder contractility index of <100, and (3) a composite of three urodynamic measures (Gammie criteria). RESULTS: Of 358 women, 172 (48%) were in the nocturia group and 186 (52%) were in the no nocturia group. On uroflowmetry, median postvoid residual volume was similar (20 mL) in both groups. Median maximum flow rate (15 vs 17 mL/s, P < 0.05) and average flow rate (6 mL/s vs 7 mL/s, P < 0.05) were significantly lower in the nocturia group compared with the no nocturia group. During pressure-flow study, a significantly greater proportion of women with nocturia were unable to void around the catheter (30% vs 27%, P < 0.01). The overall rate of DU varied with the criteria used: BVE (54%), bladder contractility index (41%), and Gammie criteria (7%). The rate of DU using the BVE criteria was significantly higher in the nocturia group (63% vs 48%, P < 0.01), but no significant differences were noted using the other criteria. CONCLUSIONS: Nocturia is associated with reduced voiding efficiency in women. The diagnosis of DU using urodynamics is challenging.

Review of Malpractice Litigations Involving Vesicovaginal and Rectovaginal Fistulas Following Elective Hysterectomy for Benign Indications in the United States From 1970 to 2020.

OBJECTIVE: The aims of this study were to review malpractice litigations involving vesicovaginal and rectovaginal fistulas after elective hysterectomy for benign indications in the United States and identify the most common themes in allegations by the plaintiffs and defenses by the defendants. METHODS: Using the Lexis Nexis legal database, we searched for and reviewed all U.S. malpractice litigations pertinent to this question between 1970 and 2020. RESULTS: Out of 82 cases that were identified and reviewed, 17 cases met our inclusion and exclusion criteria. These cases were decided between 1973 and 2019. Nine cases involved total abdominal hysterectomies, 1 involved total laparoscopic hysterectomy (TLH), 1 involved total vaginal hysterectomy (TVH), and the rest were not specified. Fifteen cases involved vesicovaginal fistulas and 2 involved rectovaginal fistulas. Three cases were ruled in favor of the plaintiffs, with monetary compensation ranging from $250,000 to $753,722 (approximately $364,120 to $1.8 million when adjusted for inflation), whereas 14 cases were ruled in favor of the defending surgeons. Common allegations were negligence in 15 cases and lack of informed consent in 2 cases. Factors that strengthened the defendants' arguments were thorough documentation, informed consent, and prompt referral to specialists. Intraoperative cystoscopy may have benefited in some cases. CONCLUSIONS: Thorough documentation, informed consent, and prompt referral to specialists strengthened the defendants' legal arguments. Intraoperative cystoscopy may also be beneficial.

Return to Baseline Functional Status in Older Women Undergoing Surgery for Pelvic Organ Prolapse.

OBJECTIVE: The aim of the study was to determine the rate of return to baseline functional status 3 months after surgery for pelvic organ prolapse (POP) in women 65 years or older. METHODS: This is a multicenter prospective cohort study of women older than 65 years undergoing POP surgery. Functional status was determined by the Activities Assessment Scale at the preoperative visit and 3 months after surgery. We compared a variety of clinical variables and preoperative functional status scores for women who worsened, improved, or returned to baseline functional status after surgery using univariable and multivariable analysis. RESULTS: A total of 192 women were enrolled in the study. Of 176 women who completed both sets of questionnaires, 59% improved, 35% returned, and 6% worsened from their baseline functional status. Variables significantly associated with postoperative functional status score were depression (P < 0.002) and preoperative functional status score (P < 0.001). The group that improved from baseline had the lowest (worst) preoperative functional status score (78.7 ± 16.4), whereas the group that worsened after surgery had the highest (best) preoperative functional status score (98.6 ± 2.2). After adjusting for age and depression, higher preoperative functional status score was predictive of failure to return to baseline functional status. CONCLUSIONS: Most older women undergoing surgery for POP, including those with low preoperative functional status, return to or improve from their baseline functional status within 3 months of surgery. Women with higher functional status before surgery are less likely to report improvement in physical functioning after surgery.

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

A Mobile Application Patient Decision Aid for Treatment of Overactive Bladder.

OBJECTIVE: The aim of this study was to develop and validate a mobile application patient decision aid (mPDA) for providing treatment options to women with overactive bladder (OAB). METHODS: We performed a mixed methods study. We conducted cognitive interviews to gain insight about treatment decisions for OAB. We then developed an evidence-based mPDA and conducted a prospective cohort study to validate it. Women completed the validated Decisional Conflict Scale. Construct validity was determined by comparing Decisional Conflict Scale scores before and after use of the decision aid. Concurrent validity was assessed by determining the relationship between change in Decision Conflict Scale score and a validated Patient Satisfaction Questionnaire. Discriminant validity was assessed by comparing the change in Decision Conflict Scale score in women who had failed 2 or less versus 3 or more prior treatments. RESULTS: Fifteen women participated in cognitive interviews. Thematic analysis revealed that women want information about adverse events, personalization of treatment options, and supplemental interactive sources. Sixty-five women participated in the validation study. Decision Conflict Scale scores improved significantly after use of the decision aid (60.2 ± 22.3 vs 18.7 ± 19.5, P < 0.001). Change in Decision Conflict Scale score correlated moderately with Patient Satisfaction Questionnaire score (r = 0.437, P = 0.003). Women with 3 or more prior treatment failures had greater improvement in Decision Conflict Scale score than women with 2 or less prior treatment failures (P < 0.001). CONCLUSIONS: The mPDA is a valuable adjunct to physician counseling for treatment options in women with OAB.

Video Virtual Clinical Encounters Versus Office Visits for Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial.

OBJECTIVES: To determine if patient satisfaction of virtual clinical encounters is noninferior to traditional in-office clinical encounters for postoperative follow-up after reconstructive surgery for pelvic organ prolapse. METHODS: This was a randomized controlled noninferiority trial of women undergoing surgery for pelvic organ prolapse. Women were recruited and randomized during their preoperative counseling visit to virtual clinical encounters via video conference technology or in-office clinical encounters for their 30-day postoperative follow-up visits. The primary outcome was patient satisfaction measured by the validated Patient Satisfaction Questionnaire-18 (score range, 18-90, with higher scores indicating greater satisfaction) administered by telephone following the 30-day visit. Additional information regarding demographics, postoperative health care utilization, and complications was collected via chart review and compared between groups. RESULTS: A total of 52 women were randomly assigned to virtual clinical encounters via videoconference technology or traditional in-office clinical encounters (26 per group). The mean patient satisfaction score was 80.7 ± 2.6 in the virtual group and 81.2 ± 2.8 in the office group (difference, -0.46 points; 95% confidence interval, -1.95 to 1.03), which was consistent with noninferiority. Postoperative complication rates were 31% in the virtual group and 46% in the office group (P = 0.3). There were no significant between-group differences in secondary measures of unscheduled telephone calls (88% versus 77%, P = 0.5) and office visits (35% versus 38%, P = 0.8), emergency room visits (15% versus 19%, P = 1.0), and hospital readmissions (4% versus 12%, P = 0.6) within 90 days of surgery. CONCLUSIONS: For patients with pelvic organ prolapse undergoing reconstructive surgery, postoperative virtual clinical encounters via video conference technology are noninferior to traditional in-office clinical encounters with high levels of short-term patient satisfaction and no differences in postoperative health care utilization and complications rates.

Performance, acceptability, and validation of a phone application bowel diary.

AIMS: To assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary). METHODS: Women reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs). RESULTS: Paired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper. CONCLUSION: The PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.

Accidental Bowel Leakage Evaluation: A New Patient-Centered Validated Measure of Accidental Bowel Leakage Symptoms in Women.

BACKGROUND: Questionnaires assessing accidental bowel leakage lack important patient-centered symptoms. OBJECTIVE: We aimed to create a valid measure of accidental bowel leakage symptoms. DESIGN: We previously created a conceptual framework capturing patient-centered accidental bowel leakage symptoms. The framework included bowel leakage type, severity and bother, and ancillary bowel symptoms, including predictability, awareness, leakage control, emptying disorders, and discomfort. SETTINGS: The study was conducted in outpatient clinics. PATIENTS: Women with at least monthly accidental bowel leakage were included. INTERVENTIONS: Participants completed the Accidental Bowel Leakage Evaluation at baseline and 12 and 24 weeks, as well as bowel diaries and other validated pelvic floor questionnaires. A subset completed items twice before treatment. Final item selection was based on psychometric properties and clinical importance. MAIN OUTCOME MEASURES: Psychometric analyses included Cronbach α, confirmatory factor, and item response theory analyses. Construct validity was based on correlations with measures of similar constructs. RESULTS: A total of 296 women completed baseline items, and 70 provided test-retest data. The cohort was predominately white (79%) and middle aged (64 ± 11 y). Confirmatory factor analyses supported the conceptual framework. The final 18-item scale demonstrated good internal consistency (Cronbach α = 0.77-0.90) and test-retest reliability (intraclass correlation = 0.80). Construct validity was demonstrated with baseline and 12- and 24-week scale scores, which correlated with the Vaizey (r = 0.52, 0.68, and 0.69), Colorectal Anal Distress Inventory (r = 0.54, 0.65, 0.71), Colorectal Anal Impact Questionnaire (r = 0.48, 0.53, 0.53), and hygiene (r = 0.39, 0.43, 0.49) and avoidance subscales scores of the adaptive index (r = 0.45, 0.44, 0.43) and average number of pad changes per day on bowel diaries (r = 0.35, 0.38, 0.31; all p < 0.001). LIMITATIONS: The study was limited by nature of involving validation in a care-seeking population. CONCLUSIONS: The Accidental Bowel Leakage Evaluation instrument is a reliable, patient-centered measure with good validity properties. This instrument improves on currently available measures by adding patient-important domains of predictability, awareness, control, emptying, and discomfort. See Video Abstract at http://links.lww.com/DCR/B172. EVALUACIóN DE FUGA INTESTINAL ACCIDENTAL: UNA NUEVA MEDIDA VALIDADA Y CENTRADA EN PACIENTES FEMENINOS CON SíNTOMAS DE FUGA INTESTINAL ACCIDENTAL: Los cuestionarios que evalúan la fuga intestinal accidental, carecen de síntomas centrados en el paciente.Nuestro objetivo fue crear una medida válida de síntomas de fuga intestinal accidental.Previamente creamos un marco conceptual centrado en el paciente, para capturar síntomas de fuga intestinal accidental. El marco incluía tipo de fuga intestinal, gravedad, molestia, y síntomas intestinales auxiliares, incluyendo previsibilidad, conciencia, control de fugas, trastornos de vaciado e incomodidad.Clínicas de pacientes externos.Mujeres con al menos una fuga intestinal accidental mensual.Las participantes completaron la Evaluación de Fuga Intestinal Accidental al inicio del estudio y a las 12 y 24 semanas, así como diarios intestinales y otros cuestionarios validados del piso pélvico. Un subconjunto completó los elementos dos veces antes del tratamiento. La selección final del elemento se basó en las propiedades psicométricas y la importancia clínica.Los análisis psicométricos incluyeron el Alfa de Cronbach, factor confirmatorio y análisis de la teoría de respuesta al elemento. La validez de constructo se basó en correlaciones con medidas de constructos similares.Un total de 296 mujeres completaron los elementos de referencia y 70 proporcionaron datos de test-retest. La cohorte fue predominantemente blanca (79%) y de mediana edad (64 +/- 11 años). Análisis factorial confirmatorio respaldó el marco conceptual. La escala final de 18 elementos, demostró una buena consistencia interna (Alfa de Cronbach = 0,77-0,90) y fiabilidad test-retest (correlación intraclase = 0,80). La validez de constructo se demostró con puntajes de escala de referencia de 12 y 24 semanas que se correlacionaron con Vaizey (r = 0,52, 0,68 y 0,69), Inventario de Ansiedad colorecto anal (r = 0,54, 0,65, 0,71), Cuestionarios de Impacto colorecto anal (r = 0,48, 0,53, 0,53) e higiene (r = 0,39, 0,43, 0,49), puntuaciones de subescalas de evitación del índice adaptativo (r = 0,45, 0,44, 0,43), número promedio de cambios de almohadilla por día, de los diarios intestinales (r = 0.35, 0.38, 0.31), todos p <.001.Validación de una población en busca de atención.El instrumento de Evaluación de Fuga Intestinal Accidental es una medida confiable, centrada en el paciente y con buenas propiedades de validez. Este instrumento mejora las medidas actualmente disponibles, al agregar dominios importantes para el paciente de previsibilidad, conciencia, control, vaciado e incomodidad. Consulte Video Resumen en http://links.lww.com/DCR/B172. (Traducción-Dr. Fidel Ruiz Healy).

Is Fluid Intake Associated With Fecal Incontinence in Women?

OBJECTIVE: The primary aim of this study was to determine if fecal incontinence (FI) is associated with self-reported fluid intake in women seeking care for pelvic floor disorders. The secondary aim was to determine the association between bowel symptoms and fluids associated with FI. METHODS: We conducted a retrospective cross-sectional study of women presenting for evaluation of pelvic floor disorders from 2009 to 2015. The presence of FI was defined as an affirmative response of any frequency to the question, "During the last 4 weeks, how often have you leaked or soiled yourself with stool?" Data on fluid intake and bowel symptoms were collected using the Questionnaire-based Voiding Diary and Colorectal-Anal Distress Inventory short form, respectively. The relationship between FI and quartiles of fluid intake, as well as the relationship between bowel symptoms and fluids associated with FI, was analyzed. RESULTS: Nine hundred twenty-four women were included: 379 (41%) with and 545 (59%) without FI. There was an association between FI and increasing total carbonated fluid intake (P = 0.009) and decreasing water intake (P = 0.009). The associations between FI and carbonated fluid intake and FI and water intake remained significant after controlling for patient characteristics (P < 0.05). There was a significant association between the symptom of straining to defecate and carbonated beverage intake (P = 0.046), which remained significant after controlling for patient characteristics (P < 0.001). CONCLUSIONS: Consumption of carbonated beverages is associated with FI in women. Intake of carbonated fluids is associated with bowel symptoms that may exacerbate FI symptoms.

Perioperative adverse events in women over age 65 undergoing robot-assisted sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Pelvic floor disorders are common among and disproportionately affect older women. There are limited data regarding perioperative adverse events in older women undergoing robot-assisted sacrocolpopexy (RASC) specifically. The aim of this study was to compare the rate of perioperative adverse events in younger (age <65 years) versus older (age >65 years) women who underwent RASC. METHODS: We conducted a retrospective cohort study of women who underwent RASC between 2013 and 2018. Postoperative adverse events were categorized according to the Clavien-Dindo classification. Our primary outcome was the rate of intraoperative adverse events and postoperative adverse events with Clavien-Dindo grade II or greater. Outcomes were compared using univariate and multivariate analysis. RESULTS: Of the 327 patients included in the study, 227 were <65 years of age and 100 were ≥65 years of age. Women ≥65 years of age had higher rates of hypertension, higher American Society of Anesthesiologist (ASA) class, and higher Charlson Comorbidity Index (CCI) scores compared with women <65 years of age; these were not associated with increased likelihood of adverse events. The overall rate of any perioperative adverse event was 18.3%. There was no statistically significant difference in the overall rate of perioperative adverse events between younger and older women (18.5% vs 18.0%, p = 0.91). CONCLUSIONS: There is no difference in rate of adverse events between women ≥65 years of age undergoing RASC and their younger counterparts.