Vaginal morphology and position associated with prolapse recurrence after vaginal surgery: A secondary analysis of the DEMAND study.

OBJECTIVE: To identify vaginal morphology and position factors associated with prolapse recurrence following vaginal surgery. DESIGN: Secondary analysis of magnetic resonance images (MRI) of the Defining Mechanisms of Anterior Vaginal Wall Descent cross-sectional study. SETTING: Eight clinical sites in the US Pelvic Floor Disorders Network. POPULATION OR SAMPLE: Women who underwent vaginal mesh hysteropexy (hysteropexy) with sacrospinous fixation or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy) for uterovaginal prolapse between April 2013 and February 2015. METHODS: The MRI (rest, strain) obtained 30-42 months after surgery, or earlier for participants with recurrence who desired reoperation before 30 months, were analysed. MRI-based prolapse recurrence was defined as prolapse beyond the hymen at strain on MRI. Vaginal segmentations (at rest) were used to create three-dimensional models placed in a morphometry algorithm to quantify and compare vaginal morphology (angulation, dimensions) and position. MAIN OUTCOME MEASURES: Vaginal angulation (upper, lower and upper-lower vaginal angles in the sagittal and coronal plane), dimensions (length, maximum transverse width, surface area, volume) and position (apex, mid-vagina) at rest. RESULTS: Of the 82 women analysed, 12/41 (29%) in the hysteropexy group and 22/41 (54%) in the hysterectomy group had prolapse recurrence. After hysteropexy, women with recurrence had a more laterally deviated upper vagina (p = 0.02) at rest than women with successful surgery. After hysterectomy, women with recurrence had a more inferiorly (lower) positioned vaginal apex (p = 0.01) and mid-vagina (p = 0.01) at rest than women with successful surgery. CONCLUSIONS: Vaginal angulation and position were associated with prolapse recurrence and suggestive of vaginal support mechanisms related to surgical technique and potential unaddressed anatomical defects. Future prospective studies in women before and after prolapse surgery may distinguish these two factors.

Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy. METHODS: A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests. RESULTS: Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m2); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores. CONCLUSIONS: In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a ß-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.

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.

Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

Five-year surgical outcomes of transvaginal apical approaches in women with advanced pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: In women with advanced prolapse, differences in vaginal apex anchoring sites may impact surgical outcomes over time. The primary aim was to compare 5-year surgical outcomes of uterosacral ligament suspension (ULS) versus sacrospinous ligament fixation (SSLF) in women with advanced (stage III-IV) prolapse. METHODS: A secondary analysis was conducted in a subset of women with advanced prolapse from a multicenter randomized trial comparing ULS versus SSLF and its extended follow-up, using publicly accessible de-identified datasets. The primary outcome was time to failure, defined as any one of (1) apical descent > 1/3 into the vaginal canal or anterior/posterior compartment beyond the hymen, (2) bothersome vaginal bulge symptoms, or (3) re-treatment. Secondary outcomes include symptom severity measured by the Pelvic Organ Prolapse Distress Inventory (POPDI) and adverse events. RESULTS: Of 285 women, 90/147 (61.2%) in ULS and 88/138 (63.8%) in SSLF had advanced prolapse. Baseline characteristics did not differ between groups except for median-vaginal deliveries (3.0 [2.0, 5.0] versus 3.0 [2.0, 4.0], p < 0.01). The median time to failure was 1.7 years ULS versus 2.0 years SSLF (p = 0.42). Surgical failure increased over time in both groups with no intergroup difference; by year 5, the estimated failure rate was 67.7% ULS versus 71.5% SSLF (adjusted difference -3.8; 95%CI [-21.9, 14.2]). No differences were noted in individual failure components (p > 0.05). POPDI scores improved over 5 years without intergroup difference (ULS -68.0 ± 61.1 versus SSLF -69.9 ± 60.3, adjusted difference -0.1 [-20.0, 19.9]). No difference in adverse events were observed (p > 0.05). CONCLUSION: In women with advanced prolapse, surgical failure, symptom severity, and adverse events did not differ between ULS and SSLF over 5 years.

Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. RESULTS: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. CONCLUSIONS: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.

Association of quality of prenatal care with contraceptive planning in a United States population: a retrospective cohort study.

BACKGROUND: Understanding how prenatal care influences planned postpartum contraception can help guide shared decision-making. This study looks to examine the association of the quality of prenatal care with planned postpartum contraception. METHODS: This is a retrospective cohort study conducted in a single tertiary, academic urban institution in the southwest United States. The institutional review board (IRB) for human research at Valleywise Health Medical Center approved this study. Using a validated measure of prenatal care, the Kessner index, prenatal care was classified as adequate, intermediate, or inadequate. The World Health Organization (WHO) protocol for contraceptive effectiveness was used to classify contraceptives as very effective, effective, and less effective. The planned contraceptive choice was determined at the time of hospital discharge after delivery by discharge summary. Chi-squared testing and logistic regression were used to measure associations between the adequacy of prenatal care and contraceptive planning. RESULTS: This study included 450 deliveries, 404 (90%) patients with adequate prenatal care, and 46 (10%) patients without adequate (intermediate or inadequate) prenatal care. There was not a statistically significant difference in planning for very effective or effective methods of contraception at hospital discharge between adequate (74%) and non-adequate (61%) prenatal care groups (p = 0.06). There was no association between the adequacy of prenatal care and the effectiveness of contraceptive planning after controlling for age and parity (aOR = 1.7, 95% CI 0.89-3.22). CONCLUSIONS: Many women chose very effective and effective methods of postpartum contraception; however, there was no statistically significant association between the quality of prenatal care and planned contraception at hospital discharge.

Improved body image after uterovaginal prolapse surgery with or without hysterectomy.

INTRODUCTION AND HYPOTHESIS: The objective was to compare body image and sexual activity and function changes up to 3 years after sacrospinous ligament fixation with graft hysteropexy or vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). METHODS: This was a planned secondary analysis of a multi-center randomized trial of women undergoing prolapse repair with mesh hysteropexy versus hysterectomy. Women were masked to intervention. The modified Body Image Scale (BIS), sexual activity status, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) scores were reported at baseline and 1.5, 6, 12, 18, 24, and 36 months after surgery. We compared mean BIS and PISQ-IR scores, the proportion of women whose BIS scores met a distribution-based estimate of the minimally important difference (MID), and sexual activity status. Comparisons were analyzed with linear and logistic repeated measures models adjusted for site, intervention, visit, and intervention by visit interaction. RESULTS: Eighty-eight women underwent mesh hysteropexy; 87 underwent hysterectomy. Women were similar with regard to baseline characteristics, mean age 65.9 ± 7.3 years, and most had stage III or IV prolapse (81%). Baseline mean BIS scores were not significantly different, improved in both groups by 1.5 months, and were sustained through 36 months with no differences between groups (all p > 0.05). The estimated BIS MID was 3; and by 36 months, more women in the mesh hysteropexy group achieved the MID than in the hysterectomy group (62% vs 44%, p = 0.04). The makeup of the sexually active cohort changed throughout the study, making function comparisons difficult. CONCLUSIONS: Body image improves following prolapse surgery whether or not hysterectomy is performed or transvaginal mesh is used at the time of repair; sexual activity status changes over time following prolapse surgery.

Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

BACKGROUND: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. OBJECTIVE: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY DESIGN: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile. RESULTS: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years. CONCLUSION: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

Characterization of symptom severity and impact on four fecal incontinence phenotypes in women presenting for evaluation.

AIM: To characterize symptom-specific distress and impact on quality of life (QOL) among women with urge, passive, and combined urge/passive fecal incontinence (FI) phenotypes. A secondary aim was to characterize FI symptom-specific distress and impact on women with a novel fourth phenotype, stress FI. METHODS: Women with at least monthly FI from 2003 to 2017 were included. Participants completed the Modified Manchester Health Questionnaire (MMHQ) including MHQ and Fecal Incontinence Severity Index (FISI). Anorectal manometry (ARM) and endoanal ultrasound (EAUS) testing was performed. Total MHQ and FISI scores were compared across FI subtypes controlling for pertinent baseline covariates. RESULTS: The cohort included 404 subjects, 220 meeting criteria for urge FI, 67 passive FI, and 117 combined urge/passive FI. On MHQ, women with combined urge/passive FI were most impacted (p < 0.01). FISI scores were significantly different from combined urge/passive FI having the greatest impact (38.1 ± 12.5) and urge FI (31.1 ± 11.3), p < 0.01 having the least. No differences were observed in ARM measurements or anal sphincter defects among the three groups (all p > 0.05). Twenty-nine subjects were identified with stress FI. There were no differences in overall MHQ or FISI scores or anal sphincter evaluation among the urge, passive, and stress FI groups (all p > 0.05). CONCLUSION: Women with combined urge/passive FI have higher symptom distress and impact on QOL than urge or passive FI alone. Further research is needed to determine the significance of stress FI as a subtype and response to treatment.

Incontinence outcomes after "second primary" compared to repeat midurethral sling for recurrent and persistent stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The current study aims to assess the continence rate of a "second primary" midurethral sling (MUS) in women with recurrent/persistent stress urinary incontinence (SUI) after sling excision compared to a historical cohort who underwent a repeat MUS. METHODS: A retrospective cohort study of women who underwent excision of a primary MUS and placement of a "second primary" MUS from 2009 to 2016 compared to a historical cohort who underwent a repeat MUS from 2006 to 2009. The primary outcome was continence rate, defined as "not at all" or "somewhat" to Urogenital Distress Inventory (UDI-6) SUI subscale questions. Secondary outcomes included assessment of symptom severity (UDI-6), symptom-specific quality of life, Incontinence Impact Questionnaire (IIQ-7), Medical and Epidemiologic Aspects of Aging (MESA), and Patient Global Impression of Improvement (PGI-I). RESULTS: Survey responses were available for 23/64 (36%) in the "second primary" MUS group versus 88/135 (65%) in the historical cohort. Mean follow-up in months, second primary: 41.8 ± 26.1 versus repeat: 36.2 ± 14.1, p = 0.16 and age (years): 56.4 ± 10.7 versus 59.8 ± 10.8, p = 0.19. Continence rates were 48% in "second primary" versus 56% in the repeat group (p = 0.50). Both groups had significant improvement in questionnaire scores postoperatively with no intergroup differences. Multivariable analysis demonstrated that odds of success did not differ between groups (adjusted odds ratio: 0.73, 95% confidence interval: 0.27-1.99). CONCLUSIONS: In women with recurrent/persistent SUI, repeat and "second primary" MUS procedures demonstrate similar success outcomes and improvement in UI symptom distress and QOL. Continued research is needed for this increasingly important clinical question.

Effect of darifenacin on fecal incontinence in women with double incontinence.

INTRODUCTION AND HYPOTHESIS: To evaluate change in fecal incontinence symptom severity after 8 weeks of darifenacin therapy in patients with double incontinence-urgency urinary incontinence (UUI) and fecal incontinence. Important secondary outcomes included fecal incontinence symptom distress and impact on quality of life, fecal incontinence episodes, global impression of improvement and overactive bladder symptom distress and impact. METHODS: Prospective open-label cohort study of women presenting primarily with UUI, diagnosed with double incontinence and electing antimuscarinic therapy for UUI. Women ≥ 18 years with moderate or greater bothersome UUI and fecal incontinence of liquid/solid stool with St. Marks (Vaizey) score ≥ 12 were included. Subjects were treated with darifenacin 15 mg daily for 8 weeks. The primary outcome was change in fecal incontinence symptom severity using the St. Marks (Vaizey) score after 8 weeks. Sample size was based on the minimally important difference of the St. Marks, -5, and standard deviation, ± 8.5; 30 subjects provided 80% power and type I error of 0.05, including a 15% attrition rate. RESULTS: Thirty-two women were consented with mean baseline St. Marks (Vaizey) score of 18.0 ± 3.0. Mean age was 66.5 ± 10.3 years. Twenty-eight subjects (29/32, 87.5%) completed assessments. St. Marks (Vaizey) score significantly improved from 18.0 to 11.0 [mean difference - 7.0, 95% confidence interval (CI): -8.7, -5.3], and 19 subjects (19/32,67.9%) met the minimally important difference. Statistically significant improvements were also noted in fecal incontinence frequency, quality of life, and overactive bladder symptom bother and quality of life (all p < 0.01). CONCLUSIONS: Darifenacin can be considered a highly effective early intervention in women suffering from double incontinence. CLINICAL TRIAL REGISTRATION: Bladder Antimuscarinic Medication and Accidental Bowel Leakage (BAMA), https://clinicaltrials.gov/ct2/show/NCT03543566 , NCT03543566.

Short-, mid-, and long-term incontinence outcomes in women undergoing mid-urethral sling procedures: a retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: The primary aim was to compare subjective treatment success among women in short-, mid-, and long-term follow-up after mid-urethral sling (MUS). Symptom severity, condition-specific quality of life (QOL), and patient satisfaction were also examined. METHODS: Women undergoing a primary MUS between 2001 and 2010 were identified by CPT code. Eligible subjects were mailed the Urogenital Distress Inventory (UDI-6), Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), and Patient Satisfaction Questionnaire (PSQ). Follow-up intervals were short term (≤ 36 months), mid term (37-70 months), and long term (119-200 months). The primary outcome of treatment success was defined as responses of "not at all" or "somewhat" to both stress urinary incontinence (SUI) subscales on the UDI-6. RESULTS: Of 896 respondents, 361 were assessed in the short-term (23.3 ± 7.2 months), 251 in the mid-term (49.8 ± 9.1 months), and 284 in the long-term group (147.9 ± 20.6 months). Treatment success was 75.4% in the short-, 62.3% in the mid-, and 67.0% in the long-term groups (p < 0.01). Logistic regression showed women with mid- and long-term follow-up were nearly half as likely as their short-term counterparts to report treatment success (adjusted odds ratio [aOR] 0.51, 95% confidence interval [CI] 0.36, 0.74). UDI-6 and PFIQ-7 scores differed significantly among the short-, mid- and long-term groups (p < 0.01). Patient satisfaction was similar, 83.3% in the short-, 76.6% in the mid-, and 78.2% in the long-term follow-up (p = 0.31). CONCLUSION: Women with short-term follow-up had the highest subjective treatment success rates; mid- and long-term follow-up was lower, but sustained after 3 years. Symptom severity and impact on QOL were lowest in the short-term group. However, high satisfaction was noted across all groups.

Impact of treatment for fecal incontinence on constipation symptoms.

OBJECTIVE: Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment. STUDY DESIGN: This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks. RESULTS: At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4). CONCLUSION: Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.

Association between adjuvant posterior repair and success of native tissue apical suspension.

BACKGROUND: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. OBJECTIVE: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. MATERIALS AND METHODS: This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤ -2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. RESULTS: Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P = 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P = 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). CONCLUSION: Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

Pelvic floor disorder symptoms and bone strength in postmenopausal women.

INTRODUCTION AND HYPOTHESIS: The current study is aimed at characterizing the association between pelvic floor disorder symptoms and bone strength reflecting a potential connective tissue pathophysiology in postmenopausal women. METHODS: A cross-sectional study was conducted in postmenopausal women undergoing osteoporosis evaluation from 2007 to 2010. Urinary incontinence (UI) was defined as urinary leakage ≥2-3 times/week. UI types were defined using the 3 Incontinence Questionnaire. Fecal incontinence was defined as stool leakage ≥1/month, and pelvic organ prolapse as a positive response to "Do you have a bulge or something falling out that you can see or feel in your vaginal area?" Bone quality and quantity were assessed using the trabecular bone score (TBS) and bone mineral density respectively: bone strength was defined by combined quality/quantity index, low strength being equivalent to moderate to severe fracture risk; low quality as TBS ≤ 1.31; low quantity by T-score <-1 or on osteoporosis medication. RESULTS: Of 681 subjects, 262 had low bone strength whereas 419 were normal using the combined quality/quantity bone assessment. Characteristics were similar except for age (low bone strength: 69.0 ± 8.2 vs normal: 65.0 ± 7.1, p < 0.01) and smoking (8.8% vs 3.3%, p < 0.01). Low bone strength was associated with any UI (adjusted odds ratio [aOR]: 1.48, 1.05-2.10), stress (aOR: 1.53, 1.06-2.21), and mixed (aOR :1.45, 1.02-2.05). Women with low bone quality had increased odds of UI (any, urgency, mixed), whereas none of the pelvic floor disorder symptoms was associated with low bone quantity. CONCLUSIONS: Low bone strength defined by a combined quantity/quality index, as well as low bone quality alone, were associated with increased risk of UI.

Self-management of accidental bowel leakage and interest in a supportive m-Health app among women.

INTRODUCTION: Self-management with clinician guidance is a cornerstone of successful conservative treatment for accidental bowel leakage (ABL). There are currently few resources to assist patients with that essential self-management. The purpose of this study was to describe self-management of ABL and explore interest in a mobile health application (m-Health app) for supporting ABL self-management among community-living women. METHODS: Using an observational/descriptive design, women (18+ years) previously seen in a urogynecology clinic for ABL were mailed a survey containing eight multiple-choice questions and an open-ended prompt for comments. RESULTS: Survey responses were received from 161 women (18% response rate). The highest percentage of participants was aged 61-70 years (39%). Nearly half of the participants (47%) "did not know anything" about ABL self-management before visiting a clinician. Only 4% "knew a lot." Of those who have been trying to self-manage their ABL (n = 132), 37% reported that it was not effective, and only 5% thought their self-management was "very effective." Half (50%) of the participants had "a lot of" interest in an m-Health app to support managing ABL, and 30% had "some" interest. The vast majority (89%) thought that it was "very important" to have ongoing guidance and support for self-managing ABL. CONCLUSIONS: Before visiting a clinician, most women with ABL lacked knowledge about ABL self-management, and their self-management was not very effective. Women thought having guidance to self-manage ABL was important. There would be good interest among women in an m-Health app supporting self-management of ABL if one were created.

Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence. METHODS: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse. RESULTS: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II. CONCLUSIONS: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

Fecal Incontinence Symptoms and Impact in Older Versus Younger Women Seeking Care.

BACKGROUND: The differential impact of aging on fecal incontinence symptom severity and condition-specific quality of life remains unclear. OBJECTIVE: The purpose of this study was to characterize differences in symptom distress, quality of life, and anorectal physiology assessments in older versus younger women with fecal incontinence. DESIGN: This was a cross-sectional study. SETTINGS: This study was conducted at a tertiary genitorectal disorder clinic. PATIENTS: Women presenting for fecal incontinence evaluation between 2003 and 2016 were classified as older or younger based on age ≥65 or <65 years. MAIN OUTCOME MEASURES: The main outcomes were symptom-specific quality of life and distress measured by validated questionnaires (the Modified Manchester Health Questionnaire containing the Fecal Incontinence Severity Index); anorectal physiology and anatomy were assessed by manometry and endoanal ultrasound. RESULTS: Of 879 subjects, 286 and 593 were classified as older and younger (mean ages, 71.4 ± 5.3 y and 51.3 ± 10.5 y). Solid stool leakage was more frequent in older women (83.2% vs 76.7%; p = 0.03), whereas liquid stool leakage (83.2% vs 82.8%; p = 0.88) and fecal urgency (76.9% vs 78.8%; p = 0.54) did not differ between groups. Mean symptom severity scores were similar between groups (28.0 ± 11.9 and 27.6 ± 13.5; p = 0.69); however, there was greater negative impact on quality of life among younger women (46.3 ± 22.0 vs 51.8 ± 21.8; p < 0.01). Multivariable linear regression controlling for pertinent covariates revealed younger age as an independent predictor for worse condition-specific quality-of-life scores (p < 0.01). Squeeze pressures were similar between groups, whereas younger women had greater resting pressures and higher rates of sphincter defects (external, 7.7% vs 20.2%; internal, 12.2% vs 26.8%; both p < 0.01). LIMITATIONS: This study was limited by its lack of patient obstetric history and the duration of their incontinence symptoms. CONCLUSIONS: Characteristics differ between older and younger women seeking care for fecal incontinence. The differential impact and age-related phenotypes may provide useful information for patient counseling and developing management algorithms for women with fecal incontinence. See Video Abstract at http://links.lww.com/DCR/A910.