Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events (AE) and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspective in the process remains lacking. OBJECTIVES: To compare clinician versus patient grading of AE severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association between patient grading of AEs with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study, "Patient-Perspectives in Adverse Event Reporting" (PPAR), to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, AEs experienced by patients were collected per a standardized protocol every 6 months where clinicians graded AE severity (mild, moderate, severe/life threatening). In this sub-study, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR AEs". Patients provided their own severity grading (mild, moderate, severe/very severe/ life threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic, κ) for AE severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. Association between AE severity and the Decision-Regret Scale (DRS), Satisfaction with Decision Scale (SDS), the Short-Form Health Survey-12 (SF-12), and Patient-Global Impression of Improvement (PGI-I) scores were assessed utilizing Spearman's correlation coefficient (ρ) for continuous scales, Mantel-Haenszel chi-squared test for PGI-I, and T-tests or chi-squared tests comparing assessments of severe vs other grades. To describe patient perspective changes over time, the intra-observer agreement was estimated for AE severity grade over time using weighted kappa-coefficients. RESULTS: Of 360 patients randomized, 219 (61%) experienced a total of 527 PPAR AEs (91% moderate and 9% severe/life threatening by clinician grading). Mean patient age was 67 years, 87% were White, and 12% Hispanic. Of patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (κ=0.24 (95%CI 0.14, 0.34). Of 414 AEs clinicians graded as moderate, patients graded 120 (29%) mild, and 80 (19%) severe. Of 39 AEs graded severe by clinicians, patients graded 15 (38%) mild or moderate. Initial patient grading of the most severe reported AE was mildly correlated with worse DRS (ρ=0.2, p=0.01), SF-12 (ρ=-0.24, p<0.01) and PGI-I (p<0.01). There was no association between AE severity and SDS. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (p<0.05). Agreement between the patients' initial severity and later timepoints was fair at 12 months (κ=0.48 (95% CI 0.39, 0.58)) and 36 months (κ=0.45 (95% CI 0.37, 0.53)). CONCLUSIONS: Clinician and patient perceptions of AE severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair.

BACKGROUND: As the muscular and connective tissue components of the vagina are estrogen responsive, clinicians may recommend vaginal estrogen to optimize tissues preoperatively and as a possible means to reduce prolapse recurrence, but long-term effects of perioperative intravaginal estrogen on surgical prolapse management are uncertain. OBJECTIVE: This study aimed to compare the efficacy of perioperative vaginal estrogen vs placebo cream in reducing composite surgical treatment failure 36 months after native tissue transvaginal prolapse repair. STUDY DESIGN: This was an extended follow-up of a randomized superiority trial conducted at 3 tertiary US sites. Postmenopausal patients with bothersome anterior or apical vaginal prolapse were randomized 1:1 to 1-g conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally twice weekly for ≥5 weeks preoperatively and continued twice weekly for 12 months postoperatively. All participants underwent vaginal hysterectomy (if the uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The primary report's outcome was time to failure by 12 months postoperatively, defined by a composite outcome of objective prolapse of the anterior or posterior walls beyond the hymen or the vaginal apex descending below one-third the total vaginal length, subjective bulge symptoms, and/or retreatment. After 12 months, participants could choose to use-or not use-vaginal estrogen for atrophy symptom bother. The secondary outcomes included Pelvic Organ Prolapse Quantification points, subjective prolapse symptom severity using the Patient Global Impression of Severity and the Patient Global Impression of Improvement, and prolapse-specific subscales of the 20-Item Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire-Short Form 7. Data were analyzed as intent to treat and "per protocol" (ie, ≥50% of expected cream use per medication diary). RESULTS: Of 206 postmenopausal patients, 199 were randomized, and 186 underwent surgery. Moreover, 164 postmenopausal patients (88.2%) provided 36-month data. The mean age was 65.0 years (standard deviation, 6.7). The characteristics were similar at baseline between the groups. Composite surgical failure rates were not significantly different between the estrogen group and the placebo group through 36 months, with model-estimated failure rates of 32.6% (95% confidence interval, 21.6%-42.0%) and 26.8% (95% confidence interval, 15.8%-36.3%), respectively (adjusted hazard ratio, 1.55; 95% confidence interval, 0.90-2.66; P=.11). The results were similar for the per-protocol analysis. Objective failures were more common than subjective failures, combined objective and subjective failures, or retreatment. Using the Patient Global Impression of Improvement, 75 of 80 estrogen participants (94%) and 72 of 76 placebo participants (95%) providing 36-month data reported that they were much or very much better 36 months after surgery (P>.99). These data included reports from 51 of 55 "surgical failures." Pelvic Organ Prolapse Quantification measurements, Patient Global Impression of Severity scores, and prolapse subscale scores of the 20-Item Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire-Short Form 7 all significantly improved for both the estrogen and placebo groups from baseline to 36 months postoperatively without differences between the groups. Of the 160 participants providing data on vaginal estrogen usage at 36 months postoperatively, 40 of 82 participants (49%) originally assigned to the estrogen group were using prescribed vaginal estrogen, and 47 of 78 participants (60%) assigned to the placebo group were using vaginal estrogen (P=.15). CONCLUSION: Adjunctive perioperative vaginal estrogen applied ≥5 weeks preoperatively and 12 months postoperatively did not improve surgical success rates 36 months after uterosacral or sacrospinous ligament suspension prolapse repair. Patient perception of improvement remained very high at 36 months.

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.

Longitudinal Reoperation Risk After Apical Prolapse Procedures in Women Aged 65 Years and Older.

OBJECTIVE: To describe longitudinal reoperation risk among older women undergoing surgery for apical pelvic organ prolapse (POP) and to compare risk of reoperation for prolapse and complications among different surgical approaches. METHODS: This nationwide, retrospective cohort study evaluated older adult women (aged 65 years and older) within the Centers for Medicare & Medicaid Services' (CMS) 5% LDS (Limited Data Set) who underwent sacrocolpopexy, uterosacral ligament suspension (USLS), sacrospinous ligament fixation (SSLF), or colpocleisis, or their uterine-preserving equivalents, from January 1, 2011, to December 31, 2018, with follow-up through 2019. The primary outcome was overall reoperation, and secondary outcomes included reoperation for POP and for complications. Rates were compared using χ 2 tests for categorical variables, Wilcoxon rank-sum for continuous variables and Kaplan Meier estimates of cumulative incidence. Death and exit from CMS insurance were considered as censoring events. We used cumulative incidence to calculate reoperation risk as a function of time at 1 year or more, 3 years or more, and 7 years or more. RESULTS: This cohort included 4,089 women who underwent surgery to treat apical POP from 2011 to 2018: 1,034 underwent sacrocolpopexy, 717 underwent USLS, 1,529 underwent SSLF, and 809 underwent colpocleisis. Demographics varied among patients for each POP surgery. Patients who underwent the different surgeries had differences in age ( P <.01), Charlson Comorbidity Index score ( P <.01), diabetes ( P <.01), chronic obstructive pulmonary disease ( P <.01), hypertension ( P <.01), chronic pain ( P =.01), congestive heart failure ( P <.01), and concomitant hysterectomy ( P <.01). Reoperation rates were low and increased over time. The overall reoperation risk through 7 years was 7.3% for colpocleisis, 10.4% for USLS, 12.5% for sacrocolpopexy, and 15.0% for SSLF ( P <.01). Reoperation for recurrent POP through 7 years was 2.9% for colpocleisis, 7.3% for sacrocolpopexy, 7.7% for USLS, and 9.9% for SSLF ( P <.01). Reoperation for complications through 7 years was 5.3% for colpocleisis, 8.2% for sacrocolpopexy, 6.4% for USLS, and 8.2% for SSLF ( P <.01). CONCLUSION: The type of surgical repair is significantly associated with long-term risk of reoperation. Colpocleisis offers the least likelihood of reoperation for prolapse, followed by sacrocolpopexy; colpocleisis followed by USLS has the least risk of long-term reoperation for complication.

Correlation Between Mobile-Application Electronic Bowel Diary and Validated Questionnaires in Women with Fecal Incontinence.

INTRODUCTION AND HYPOTHESIS: Despite growing interest in a mobile-app bowel diary to assess fecal incontinence (FI) symptoms, data are limited regarding the correlation between mobile-app diary and questionnaire-based outcomes. The primary aim is to determine whether percentage reduction in FI episodes (FIEs)/week recorded on a mobile-app diary correlates with changes in scores of validated FI-symptom measures from baseline to 12 weeks in women with FI undergoing percutaneous tibial nerve stimulation (PTNS) versus sham. METHODS: This is a planned secondary analysis of a multicenter randomized trial in which women with FI underwent PTNS or sham. FIEs were collected using a mobile-app diary at baseline and after 12 weekly sessions. FI-symptom-validated measures included St. Mark's, Accidental Bowel Leakage Evaluation, FI Severity Index (FISI), Colorectal Anal Distress Inventory, Colorectal Anal Impact Questionnaire, FI Quality of Life, Patient Global Impression of Improvement (PGI-I), and Patient Global Symptom Control (PGSC) rating. Spearman's correlation coefficient (ρ) was computed between %-reduction in FIEs/week and change in questionnaire scores from baseline to 12 weeks. Significance was set at 0.005 to account for multiple comparisons. RESULTS: Baseline characteristics of 163 women (109 PTNS, 54 sham) include mean age 63.4±11.6, 81% white, body mass index 29.4±6.6 kg/m2, 4% previous FI surgeries, 6.6±5.5 FIEs/week, and St. Mark's score 17.4±2.6. A significant correlation was demonstrated between %-reduction in FIEs/week and all questionnaires (p<0.005). A moderate-strength correlation (|ρ|>0.4) was observed for St. Mark's (ρ=0.48), FISI (ρ=0.46), PGI-I (ρ=0.51), and PGSC (ρ=-0.43). CONCLUSIONS: In women with FI randomized to PTNS versus sham, a moderate correlation was noted between FIEs measured via mobile-app diary and FI-symptom-validated questionnaire scores.

Characteristics Associated With Surgical Failure After Native Tissue Apical Prolapse Repair.

OBJECTIVE: To identify clinical and demographic characteristics associated with prolapse recurrence by 12 months after native tissue transvaginal repair. METHODS: This was a planned secondary analysis of a randomized trial including postmenopausal participants with stage 2 or greater apical or anterior vaginal prolapse scheduled for surgical repair at three U.S. sites. Participants underwent vaginal hysterectomy (if uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The intervention was perioperative (5 weeks or more preoperatively and 12 months postoperatively) vaginal estrogen compared with placebo cream. The primary outcome was time to failure by 12 months after surgery, defined by objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, symptomatic vaginal bulge, or retreatment. For this analysis, participants were grouped according to failure compared with success, and multiple factors were compared, including age, time since menopause, race and ethnicity, parity, body mass index (BMI), baseline genital hiatus measurement, prolapse stage and point of maximal prolapse, surgery type (uterosacral or sacrospinous ligament suspension), and concomitant procedures. Factors were assessed for association with the hazard of surgical failure using Cox proportional hazards models, adjusted for site and treatment group. Factors with P <.50 from this analysis were considered for inclusion in the final multivariable model; site and treatment group were kept in this model. RESULTS: One hundred eighty-six participants underwent surgery; 183 provided complete data. There were 30 failures (16.4%) and 153 successes (83.4%) at 12 months. On bivariate analysis, failure was associated with decreasing age, shorter duration since menopause, Latina ethnicity, and greater baseline genital hiatus. In the final multivariable model, which included age, BMI, and point of maximal prolapse, only age remained significantly associated with surgical failure (adjusted hazard ratio [per year] 0.92, 95% CI, 0.86-0.98, P =.016). CONCLUSION: Among postmenopausal women, younger age was associated with increased frequency of prolapse recurrence by 12 months after native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02431897.

Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial.

Importance: Surgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain. Objective: To compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair. Design, Setting, and Participants: This randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020. Interventions: The intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation). Main Outcomes and Measures: The primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events. Results: Of 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen. Conclusions and Relevance: Adjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair. Trial Registration: ClinicalTrials.gov Identifier: NCT02431897.

Effects of Same-Day Discharge on 30-Day Readmission Rates in Women Aged 65 Years and Older Undergoing Minimally Invasive Pelvic Organ Prolapse Surgery.

OBJECTIVE: To compare the effects of same-day discharge on 30-day readmission after minimally invasive pelvic organ prolapse (POP) surgery in older patients. METHODS: This retrospective cohort study examined all minimally invasive POP surgeries performed and included in the national Centers for Medicare & Medicaid Services 5% Limited Data Set (2011-2018). Our primary outcome was 30-day hospital readmission, and our secondary outcome was 30-day emergency department (ED) visits. RESULTS: Of the 7,278 patients undergoing surgery, patients who had same-day discharge were older (73.5 years vs 73.1 years, P =.04) and less likely to undergo concomitant hysterectomy (9.5% vs 34.9%, P <.01) or midurethral sling (36.8% vs 40.1%, P =.02). Same-day discharge increased over the study period from 15.7% in 2011 to 25.5% in 2018 ( P <.01). On propensity score-matching multiple logistic regression, the adjusted difference was statistically significant, with same-day discharge increasing the odds of 30-day readmission compared with next-day discharge (adjusted odds ratio [OR] 1.57, 95% CI 1.19-2.08). There was no difference (OR 0.81, 95% CI 0.63-1.05) for 30-day ED visits on propensity score-matching multiple logistic regression. CONCLUSION: After minimally invasive POP surgery, older women have low rates of readmission and ED visits within 30 days. After propensity score matching and adjustment for perioperative factors, there may be increased odds in readmission and no difference in ED visits risk in those who had same-day discharge. When considering patient factors, same-day discharge after minimally invasive POP surgery may be effective for older patients.

Effects of preoperative intravaginal estrogen on pelvic floor disorder symptoms in postmenopausal women with pelvic organ prolapse.

BACKGROUND: Menopause and the decline in systemic estrogen are associated with the development of pelvic floor disorders, such as prolapse, urinary incontinence, overactive bladder, and vulvovaginal atrophy symptoms. Past evidence suggests that postmenopausal women with symptomatic prolapse gain benefit from the preoperative application of intravaginal estrogen, but it is unknown whether they would experience improvement in other pelvic floor symptoms when treated with intravaginal estrogen. OBJECTIVE: This study aimed to determine the effects of intravaginal estrogen (compared with placebo) on stress and urgency urinary incontinence, urinary frequency, sexual function and dyspareunia, and vaginal atrophy symptoms and signs in postmenopausal women with symptomatic prolapse. STUDY DESIGN: This was a planned ancillary analysis of a randomized, double-blind trial, "Investigation to Minimize Prolapse Recurrence Of the Vagina using Estrogen," which included participants with ≥stage 2 apical and/or anterior prolapse scheduled for transvaginal native tissue apical repair at 3 US sites. The intervention was 1 g conjugated estrogen intravaginal cream (0.625 mg/g) or identical placebo (1:1), inserted nightly for 2 weeks and then twice weekly for ≥5 weeks total before surgery and continued twice weekly for 1 year postoperatively. For this analysis, question responses were compared from participants' baseline and preoperative visits: lower urinary tract symptoms (Urogenital Distress Inventory-6 Questionnaire); sexual health questions, including dyspareunia (Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA-Revised); and atrophy-related symptoms (dryness, soreness, dyspareunia, discharge, and itching; each scored 1-4, 4 being quite a bit bothersome). Masked examiners assessed vaginal color, dryness, and petechiae (each scored 1-3, total range 3-9, with 9 being the most estrogenized appearing). Data were analyzed by intent to treat and "per protocol" (ie, those adherent with ≥50% of expected intravaginal cream use, per objective tube before and after weights). RESULTS: Of 199 participants randomized (mean age of 65 years) and contributing baseline data, 191 had preoperative data. The characteristics were similar between groups. Total Urogenital Distress Inventory-6 Questionnaire scores showed minimal change during this median time of 7 weeks between baseline and preoperative visits, but for those with at least moderately bothersome baseline stress urinary incontinence (32 in the estrogen group and 21 in the placebo group), 16 (50%) in the estrogen group and 9 (43%) in the placebo group showed improvement (P=.78). In addition, 43% of participants in the estrogen group and 31% of participants in the placebo group showed improvement in urgency urinary incontinence (P=.41), and 41% of participants in the estrogen group and 26% of participants in the placebo group showed improvement in urinary frequency (P=.18). There was minimal change in the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-IUGA-Revised scores among sexually active women; dyspareunia rates did not differ between intravaginal estrogen and placebo at the preoperative assessment: 42% and 48%, respectively (P=.49). The maximum score for most bothersome atrophy symptom (among those with baseline symptoms and adherent to study cream) improved slightly more with intravaginal estrogen (adjusted mean difference, -0.33 points; 95% confidence interval, -0.98 to 0.31), but this was not statistically significant (P=.19). However, on examination, among adherent participants, objective signs of atrophy were more improved with intravaginal estrogen treatment (+1.54 vs +0.69; mean difference, 0.85; 95% confidence interval, 0.05-1.65; P=.01). CONCLUSION: Despite objective changes in the vaginal epithelium consistent with increased estrogenization among drug-adherent participants, the results were inconclusive regarding whether 7 weeks of preoperative intravaginal estrogen cream in postmenopausal women with symptomatic pelvic organ prolapse was associated with improved urinary function, sexual function, dyspareunia symptoms, and other symptoms commonly attributed to atrophy. Additional study is needed.

Endometrial Cancer Surgery With or Without Concomitant Stress Urinary Incontinence Surgery.

OBJECTIVE: To compare quality of life (QOL) among patients with endometrial intraepithelial neoplasia or early-stage endometrial cancer and stress urinary incontinence (SUI) who chose to have concomitant surgery with cancer surgery alone. METHODS: A multicenter, prospective cohort study was conducted across eight U.S. sites. Potentially eligible patients were screened for SUI symptoms. Those who screened positive were offered referral to urogynecology and incontinence treatment, including concomitant surgery. Participants were categorized into two groups: 1) concomitant cancer and SUI surgery or 2) cancer surgery alone. The primary outcome was cancer-related QOL as measured by the FACT-En (Functional Assessment of Cancer Therapy-Endometrial) (range 0-100; higher score indicates better QOL). The FACT-En and questionnaires assessing urinary symptom-specific severity and effects were assessed before surgery and 6 weeks, 6 months, and 12 months after surgery. Adjusted median regression accounting for clustering was used to examine the relationship between SUI treatment group and FACT-En scores. RESULTS: Of 1,322 (53.1%) patients, 702 screened positive for SUI with 532 analyzed; 110 (21%) chose concomitant cancer and SUI surgery, and 422 (79%) chose cancer surgery alone. FACT-En scores increased for both the concomitant SUI surgery and cancer surgery-only groups from the preoperative to the postoperative period. After adjustment for timepoint and preoperative covariates, the median change in FACT-En score (postoperative-preoperative) was 1.2 points higher (95% CI -1.3 to 3.6) for the concomitant SUI surgery group compared with the cancer surgery-only group across the postoperative period. Median time until surgery (22 days vs 16 days; P <.001), estimated blood loss (150 mL vs 72.5 mL; P <.001), and operative time (185.5 minutes vs 152 minutes; P <.001) were all greater for the concomitant cancer and SUI surgery group compared with the cancer-only group, respectively. CONCLUSION: Concomitant surgery did not result in improved QOL compared with cancer surgery alone for endometrial intraepithelial neoplasia and patients with early-stage endometrial cancer with SUI. However, FACT-En scores were improved in both groups.

Nonoperative Management of Pelvic Organ Prolapse.

Pelvic organ prolapse (POP) is defined as the descent of one or more of the anterior, posterior, or apical vagina. It is a common condition, with up to 50% of women having prolapse on examination in their lifetimes. This article provides an overview of the evaluation and discussion of nonoperative management of POP for the obstetrician-gynecologist (ob-gyn), with consideration of recommendations from the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, and the International Urogynecological Association. The initial evaluation of POP requires a history documenting whether the patient is experiencing symptoms and what they are, and discovery of which symptoms they believe are attributable to prolapse. Examination determines the vaginal compartment(s) and to what degree prolapse exists. In general, only patients who have symptomatic prolapse or medical indication should be offered treatment. Although surgical options exist, all patients who are symptomatic and desire treatment should be offered nonsurgical treatment first, including pelvic floor physical therapy or a pessary trial. Appropriateness, expectations, complications, and counseling points are reviewed. Educational opportunities between the patient and the ob-gyn include disentangling common beliefs that the bladder is dropping or that concomitant urinary or bowel symptoms are necessarily caused by prolapse. Improving patient education can lead to a better understanding of their condition and better alignment of treatment goals and expectations.

Overactive Bladder and Cognitive Impairment: The American Urogynecologic Society and Pelvic Floor Disorders Research Foundation State-of-the-Science Conference Summary Report.

IMPORTANCE: Overactive bladder (OAB) is prevalent in older adults in whom management is complicated by comorbidities and greater vulnerability to the cognitive effects of antimuscarinic medications. OBJECTIVES: The aim of this study is to provide a comprehensive evidence-based summary of the 2021 State-of-the-Science (SOS) conference and a multidisciplinary expert literature review on OAB and cognitive impairment. STUDY DESIGN: The American Urogynecologic Society and the Pelvic Floor Disorders Research Foundation convened a 3-day collaborative conference. Experts from multidisciplinary fields examined cognitive function, higher neural control of the OAB patient, risk factors for cognitive impairment in older patients, cognitive effects of antimuscarinic medications for OAB treatment, OAB phenotyping, conservative and advanced OAB therapies, and the need for a multidisciplinary approach to person-centered treatment. Translational topics included the blood-brain barrier, purine metabolome, mechanotransduction, and gene therapy for OAB targets. RESULTS: Research surrounding OAB treatment efficacy in cognitively impaired individuals is limited. Short- and long-term outcomes regarding antimuscarinic effects on cognition are mixed; however, greater anticholinergic burden and duration of use influence risk. Oxybutynin is most consistently associated with negative cognitive effects in short-term, prospective studies. Although data are limited, beta-adrenergic agonists do not appear to confer the same cognitive risk. CONCLUSIONS: The 2021 SOS summary report provides a comprehensive review of the fundamental, translational, and clinical research on OAB with emphasis on cognitive impairment risks to antimuscarinic medications. Duration of use and antimuscarinic type, specifically oxybutynin when examining OAB treatments, appears to have the most cognitive impact; however, conclusions are limited by the primarily cognitively intact population studied. Given current evidence, it appears prudent to minimize anticholinergic burden by emphasizing nonantimuscarinic therapeutic regimens in the older population and/or those with cognitive impairment.

Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment.

INTRODUCTION AND HYPOTHESIS: Factors that contribute to reoperation and surgical approaches for the management of recurrent uterovaginal prolapse after vaginal mesh hysteropexy (mesh hysteropexy) are unknown. We aimed to describe surgical management of pelvic organ prolapse recurrence after vaginal mesh hysteropexy, and patient characteristics in those who chose reoperation. METHODS: This is a descriptive analysis of women who experienced treatment failure within 5 years of mesh hysteropexy in a multi-site randomized trial. The composite definition of treatment failure included retreatment (pessary or reoperation), prolapse beyond the hymen, or bothersome prolapse symptoms. Characteristics of those pursuing and not pursuing repeat prolapse surgery, measures of prolapse, and symptom severity are described. RESULTS: Over 5-year follow up, 31/91 (34%) of the hysteropexy group met treatment failure criteria. All seven women who pursued reoperation reported bothersome prolapse symptoms; six were anatomic failures. Most seeking reoperation were early treatment failures; six (86%) by the 12-month visit and all by the 18-month visit. Compared to those electing expectant management, those pursuing reoperation had more apical prolapse, POP-Q point C median (IQR) -5.5 (-6.0, -4.0) cm versus +1.0 (-1.0, 3.0) cm respectively. Hysterectomy was performed in 6/7 reoperations (three vaginal, three endoscopic), with apical suspension in 5/6 hysterectomies. One participant with posterior compartment prolapse underwent transvaginal enterocele plication, uterosacral ligament suspension with posterior colpoperineorrhaphy. At a mean surgical follow-up of 34.3 (15.8) months, all women remained without anatomic or symptomatic failure. CONCLUSIONS: When recurrent prolapse after mesh hysteropexy occurred, most women did not choose reoperation. Those who pursued surgery experienced more significant apical prolapse and were universally symptomatic. CLINICAL TRIAL IDENTIFICATION NUMBER: NCT01802281.

Underrepresentation in Pelvic Floor Disorder Patient-Reported Outcomes: Whose Outcomes Are We Measuring?

IMPORTANCE: Patient-reported outcome (PRO) instruments measure the patient's perspective. It is unclear whether commonly used PRO measures were tested in populations that had racial and ethnic distributions comparable with those reported in U.S. census data. OBJECTIVE: The aim of this study was to compare the proportion of non-White race and Hispanic ethnicity participants with their expected proportion based on U.S. census data for PRO instruments with U.S.-based validation studies. STUDY DESIGN: This was a retrospective review of PRO measures considered by the Pelvic Floors Disorders Consortium Working Group on Patient-Reported Outcomes in their 2020 consensus publication. Study and participant information were abstracted from PRO validation studies. Racial and ethnic representation in U.S.-based studies were compared with U.S. census data. The primary outcome was the representation quotient of reported races and ethnicities, calculated as the reported percentage of the study population identifying with a race and/or ethnicity divided by the proportion of the U.S. population identifying with that race and/or ethnicity when the study was published. RESULTS: Forty-five studies with 21,080 total participants were included. Race was reported in 17 of 45 studies (37.8%), and ethnicity was reported in 7 of 45 (15.6%). Most studies did not specify how race and ethnicity information was collected. For U.S.-based studies, the representation quotient of White participants from 1995 to 2019 was 1.15. Indigenous American/Native American/American Indian/Alaska Natives had the lowest representation quotient (0.22). Reporting of ethnicity increased over time (P = 0.001), although there was no significant change in the reporting of race or the representation of various races and ethnicities (P > 0.05). CONCLUSION: Non-White and Hispanic patients may be underrepresented in U.S.-based validation studies for PRO instruments in pelvic floor disorders.

Summary: 2021 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse.

(1) Background: There is wide variation in the reported prevalence rates for pelvic organ prolapse (POP). There is also wide variation in the rate at which surgical interventions for pelvic organ prolapse are performed, as well as the type of interventions undertaken. As part of the International Consultation on Incontinence (ICI), our committee was tasked to produce evidence-based pathways for the surgical management of POP, any associated stress urinary incontinence (SUI), and bowel dysfunction. (2) Methods: To enable us to generate such evidence, we undertook a thorough search for the POP surgery-related, English-language scientific literature published up to April 2021. (3) Results: The committee evaluated the literature and made recommendations based on the Oxford grading system. (4) Conclusions: This review serves to provide a summary of the 2021 ICI surgical management of an evidence-based prolapse pathway and outline the evidence used to inform this guidance.

AUGS-PERFORM: A New Patient-Reported Outcome Measure to Assess Quality of Prolapse Care.

Patient-reported outcomes (PRO) are important for measuring quality of care, particularly for interventions aimed at improving symptom bother such as procedures for pelvic organ prolapse. We aimed to create a concise yet comprehensive PRO measurement tool to assess pelvic organ prolapse care in high-volume clinical environments. Methods: The relevant concepts to measure prolapse treatment quality were first established through literature review, qualitative interviews, and a patient and provider-driven consensus-building process. Extant items mapping to these concepts, or domains, were identified from an existing pool of patient-reported symptoms and condition-specific and generic health-related quality of life measures. Item classification was performed to group items assessing similar concepts while eliminating items that were redundant, inconsistent with domains, or overly complex. A consensus meeting was held in March 2020 where patient and provider working groups ranked the remaining candidate items in order of relevance to measure prolapse treatment quality. After subsequent expert review, the revised candidate items underwent cognitive interview testing and were further refined. Results: Fifteen relevant PRO instruments were initially identified, and 358 items were considered for inclusion. After 2 iterative consensus reviews and 4 rounds of cognitive interviewing with 19 patients, 11 final candidate items were identified. These items map 5 consensus-based domains that include awareness and bother from prolapse, physical function, physical discomfort during sexual activity, pain, and urinary/defecatory symptoms. Conclusions: We present a concise set of candidate items that were developed using rigorous patient-centered methodology and a national consensus process, including urogynecologic patients and providers.

Adverse outcomes after minimally invasive surgery for pelvic organ prolapse in women 65 years and older in the United States.

INTRODUCTION AND HYPOTHESIS: To describe complications at the time of surgery, 90-day readmission and 1-year reoperation rates after minimally invasive pelvic organ prolapse (POP) in women > 65 years of age in the US using Medicare 5% Limited Data Set (LDS) Files. METHODS: Medicare is a federally funded insurance program in the US for individuals 65 and older. Currently, 98% of individuals over the age of 65 in the US are covered by Medicare. We identified women undergoing minimally invasive POP surgery, defined as laparoscopic or vaginal surgery, in the inpatient and outpatient settings from 2011-2017. Patient and surgical characteristics as well as adverse events were abstracted. We used logistic regression for complications at index surgery and Cox proportional hazards regression models for time to readmission and time to reoperations. RESULTS: A total of 11,779 women met inclusion criteria. The mean age was 72 (SD ± 8) years; the majority were White (91%). Most procedures were vaginal (76%) and did not include hysterectomy (68%). The rate of complications was 12%; vaginal hysterectomy (aOR 2.4, 95% CI 2.2-2.7) was the factor most strongly associated with increased odds of complications. The 90-day readmission rate was 7.3%. The most common reason for readmission was infection (2.0%), three quarters of which were urinary tract infections. Medicaid eligibility (aHR 1.5, 95% CI 1.3-1.8) and concurrent sling procedures (aHR 1.2, 95% CI 1.04-1.4) were associated with a higher risk of 90-day readmission. The 1-year reoperation rate was 4.5%. The most common type of reoperation was a sling procedure (1.8%). Obliterative POP surgery (aHR 0.6, 95% CI 0.4-0.9) was associated with a lower risk of reoperation than other types of surgery. CONCLUSIONS: US women 65 years and older who are also eligible to receive Medicaid are at higher risk of 90-day readmission following minimally invasive surgery for POP with the most common reason for readmission being UTI.

Oral phenazopyridine vs intravesical lidocaine for bladder onabotulinumtoxinA analgesia: a randomized controlled trial.

BACKGROUND: The efficacy of intradetrusor onabotulinumtoxinA injections for the management of idiopathic overactive bladder has been well-established. The injections are typically performed in the office setting using local analgesia, most commonly a 20 to 30-minute intravesical instillation of lidocaine. There are limited data evaluating alternative bladder analgesics. OBJECTIVE: To compare pain scores with preprocedure oral phenazopyridine vs intravesical lidocaine in women undergoing intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder. STUDY DESIGN: Nonpregnant adult females with idiopathic overactive bladder, scheduled for office injection of 100 units of intradetrusor onabotulinumtoxinA were randomized to either 200 mg of oral phenazopyridine taken 1 to 2 hours preprocedure or a 20-minute preprocedure intravesical instillation of 50 mL of 2% lidocaine. We excluded participants with neurogenic bladders, and those who had received intradetrusor onabotulinumtoxinA injections in the previous 12 months. The primary outcome was pain measured by a 100-mm visual analog scale. Demographic characteristics and overall satisfaction with the procedure were also recorded. Providers answered questions about cystoscopic visualization, ease of procedure, and perception of participant comfort. Prespecified noninferiority margin was set to equal the anticipated minimum clinically important difference of 14 mm. A planned sample of 100 participants, 50 in each treatment arm, provided 80% power to detect noninferiority at a significance level of.05. We performed a modified intention-to-treat analysis and compared variables with the t test or the Fisher exact test. RESULTS: A total of 111 participants were enrolled, and complete data were obtained for 100 participants; 47 participants were randomized to phenazopyridine and 53 to lidocaine. Baseline characteristics did not differ between groups. There were 19.6% and 20.8% of participants in the phenazopyridine and lidocaine groups, respectively, who previously underwent intradetrusor onabotulinumtoxinA injections. The mean postprocedure pain was 2.7 mm lower in the phenazopyridine group than in the lidocaine group (95% confidence interval, -11.3 to 10.7), demonstrating noninferiority. More than 90% of participants in both groups stated that the pain was tolerable. Slightly more participants reported being "very satisfied" in the lidocaine group, although this was not statistically significant (50.0% vs 40.4%; P=.34). Providers reported clear visualization in 89.4% of participants in the phenazopyridine group and in 100% of participants in the lidocaine group (P=.02). Provider perception of participant comfort and overall ease of procedure were not different between groups. Length of time in the exam room was significantly shorter in the phenazopyridine than in the lidocaine group (44.4 vs 57.5 minutes; P=.0003). CONCLUSION: In women receiving intradetrusor onabotulinumtoxinA injections for idiopathic overactive bladder, oral phenazopyridine was noninferior to intravesical lidocaine for procedural pain control. Phenazopyridine is well-tolerated by participants, allows for the procedure to be performed with similar ease, and is associated with shorter appointment times.

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.

Overactive bladder medication: Anticholinergics versus mirabegron by specialty.

PURPOSE: The primary aim of this study was to identify high prescribing specialties of overactive bladder (OAB) medications for Medicare Part D beneficiaries, and describe prescribing trends by specialty from 2013 to 2017. The secondary aim was to compare the proportion of medication claims by medication class in each specialty. METHODS: We used the Medicare Part D Provider Public Use File to identify the four highest prescribing specialties from 2013 to 2017. We then compared patterns of OAB medication prescription for beneficiaries over 65 years of age between specialties. The number of medication claims, cost, and region were considered. OAB medications were classified as anticholinergic or mirabegron for additional comparison. The primary outcome was the number of OAB medication claims, and the secondary outcome was the proportion of mirabegron claims of all medication claims. RESULTS: Primary care providers (PCPs), urology, obstetrics and gynecology (OB/GYNs), and other specialties prescribed the most OAB medications. Total claims increased from 4.06 million in 2013 to 4.51 million in 2017. Mirabegron increased from 65,520 to 892,996 claims. PCPs prescribed the most OAB medications. Urologists had the highest proportion of mirabegron prescribing (19.6%), with an increased odds of mirabegron prescribing compared to OBGYNs (aOR 1.18, 95% CI 1.16-1.19). Compared to OBGYNs, PCPs, and other specialties demonstrated decreased odds of prescribing mirabegron (aOR 0.92 with 95% CI 0.91-0.93, and aOR 0.90 with 95% CI 0.88-0.91, respectively). CONCLUSION: In Medicare Part D beneficiaries, PCPs prescribed the most OAB medications between 2013 and 2017. Urologists were most likely to prescribe mirabegron.