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Importance: Pelvic organ prolapse recurrence following native tissue repair occurs with composite failure rates of 9-19% within 12 months, predominantly involving apical/anterior compartments. Objective The objective of this study was to develop a novel vaginal orthosis (NVO) device prototype through an iterative design process based on investigator and user feedback., Study Design: The NVO was designed based on pelvic floor biomechanical principles to mitigate unopposed intra-abdominal pressure of the anterior vagina by absorbing and redirecting intra-abdominal forces to the levator ani and tailored to accommodate postoperative vaginal caliber and axis. Prototypes were fabricated by 3D-printing negative molds, cast, and cured with medical-grade biocompatible silicone. Ten healthy volunteers were recruited to provide qualitative feedback for iterative design refinement (phase 0)., Results: Through an iterative engineering design process, initial concepts were refined to align with the natural, resting H-shape of the vagina. Key features included a distal self-retaining feature, posterior curvature, proximal taper, and apical/anterior contact areas for support. A more rigid material to withstand intra-abdominal forces without folding was required; therefore, Shore A60 (medium soft) instead of A40 (soft) silicone was used. Based on participant feedback, the NVO retaining feature width range was reduced (47.5-63 mm to 45-50 mm) to decrease pressure on lateral vaginal walls and levator ani distally maintaining self-retaining function. Updates to the fitting and education process also provided increased descriptive instructions for insertion and removal., Conclusions: A novel vaginal orthosis was designed specifically tailored to facilitate wound healing using an orthomedical model, improving the design through iterative feedback., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)

Importance: The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined., Objective: To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy., Design, Setting, and Participants: This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023., Interventions: Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair., Main Outcomes and Measures: The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events., Results: Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia., Conclusions and Relevance: Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach., Trial Registration: ClinicalTrials.gov Identifier: NCT02676973.

Background: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed., Objective: This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months., Study Design: This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons., Results: A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject's own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported., Conclusion: Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Abstract: Concurrent cervical cancer with advanced pelvic organ prolapse is rare: there are no well-established treatment recommendations. It is hypothesized that chronic irritation, as with long-standing pelvic organ prolapse, may lead to dysplasia and human papillomavirus-independent carcinoma, which represents only 5% of cervical cancers. Two patients with complete uterine procidentia were referred to gynecologic oncology with cervical squamous cell carcinoma; both were clinically staged as International Federation of Gynaecology and Obstetrics IB3. Treatment planning was complicated by procidentia in both cases. Standard definitive treatment of locally advanced cervical cancer is radiation therapy and concurrent chemotherapy; however, the mobility and externalization of the target lesion raised concerns regarding anatomic reproducibility during radiation treatment. After multidisciplinary team discussion (gynecologic oncology, urogynecology, radiation oncology), surgical resection and co-management with gynecologic oncology and urogynecology were successfully performed for definitive management for both patients. Although rare, this case study demonstrates the importance of multidisciplinary coordination in these complex clinical scenarios., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)

Importance: The associated effect of duration of the second stage of labor (SSL) on pelvic floor symptoms development is not well studied., Objective: This study aimed to examine the association between duration of SSL and pelvic floor symptoms at 6 months postpartum among primiparous women., Study Design: A planned secondary analysis of a multicenter randomized trial evaluating the impact of immediate versus delayed pushing on vaginal delivery rates, maternal morbidity, and neonatal outcomes was conducted between 2014 and 2018. For pelvic floor arm participants, demographic, pelvic examination, and validated questionnaire data were collected postpartum. Primary outcome was change in Pelvic Floor Distress Inventory 20 (PFDI-20) score from immediate to 6 months postpartum. Secondary outcomes included changes in the Pelvic Floor Impact Questionnaire, Fecal Incontinence Severity Index, Modified Manchester Health Questionnaire scores, and Pelvic Organ Prolapse Quantification measurements at 6 months postpartum. Participants were analyzed by SSL duration ≤60 minutes or >60 minutes., Results: Of the 2,414 trial participants, 767 (32%) completed pelvic floor assessments at 6 months. Pelvic Floor Distress Inventory 20 scores significantly improved at 6 months in the ≤60 minutes SSL group compared with >60 minutes SSL (-14.3 ± 48.0 and -3.2 ± 45.3, respectively; P = 0.04). Changes from immediate postpartum in total and subscale scores for other questionnaires at 6 months did not differ between groups. Prolapse stage did not differ between groups. Perineal body was significantly shorter in the >60 minutes SSL group (3.7 ± 0.7, 3.5 ± 0.8; P = 0.03)., Conclusions: Women with SSL >60 minutes experience less improvement in PFDI-20 scores at 6 months. Greater tissue and innervation trauma in those with SSL >60 minutes may explain persistently less improvement in PFDI-20 scores., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)

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., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (© 2023. The International Urogynecological Association.)

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.

Objective: To assess whether immediate or delayed pushing in the second-stage results in higher risk of pelvic floor morbidity., Methods: This study was a planned secondary aim of a multicenter randomized clinical trial that included nulliparous patients at 37 weeks of gestation or greater in labor with neuraxial analgesia. Participants were randomized in the second stage to initiate pushing immediately or wait 60 minutes before pushing. Participants had pelvic floor assessments at 1-5 days postpartum, 6 weeks postpartum, and 6 months postpartum. Rates of perineal lacerations, pelvic organ prolapse quantification (POP-Q) measures, and scores on validated symptom-specific distress and quality-of-life questionnaires (PFDI-20 [Pelvic Floor Distress Inventory], PFIQ [Pelvic Floor Impact Questionnaire], FISI [Fecal Incontinence Severity Index], and MMHQ [Modified Manchester Health Questionnaire]) were compared. It was estimated that 630 participants would provide more than 80% power to detect a 40% difference in second-degree or greater perineal lacerations and approximately 80% power to detect a 40% difference in stage 2 or greater pelvic organ prolapse (POP)., Results: Among 2,414 participants in the primary trial conducted between May 19, 2014, and December 16, 2017, 941 (39%) had pelvic floor assessments: 452 immediate pushing and 489 delayed pushing. The mean age was 24.8 years, and 93.4% had vaginal delivery. There were no significant differences in perineal lacerations at delivery and POP at 6 weeks and 6 months postpartum. Changes from baseline in total and subscale scores for the PFDI-20, the PFIQ, and the MMHQ were not significantly different at 6 weeks postpartum and 6 months postpartum. The change in FISI score was higher in the immediate pushing group at 6 months (2.9±5.7 vs 2.0±4.5, difference 0.9, P =.01), but less than the minimum important difference of 4., Conclusion: Among nulliparous patients in the second stage with neuraxial analgesia, immediate pushing, compared with delayed pushing, did not increase perineal lacerations, POP-Q measures, or patient-reported pelvic floor symptoms at 6 weeks and 6 months postpartum., Clinical Trial Registration: ClinicalTrials.gov , NCT02137200., Competing Interests: Financial Disclosure Methodius G. Tuuli reports that money was paid to his institution from the NIH and the Gates Foundation. Holly E. Richter reports the following: Renovia-research funding (SUI, FI); Up to Date-Royalties; NIA-research funding; NIDDK-research funding; NICHD-research funding; Obstet Gynecol & IUJ, travel reimbursement related to editor duties; Worldwide Fistula Fund, board; DSMB Bluewind; Symposia Medicus-CME speaker. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years., Objective: This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse., Study Design: This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors., Results: In the final multivariable model, body mass index (increase of 5 kg/m 2 : adjusted hazard ratio, 1.7; 95% confidence interval, 1.3-2.2; P<.001) and duration of prolapse symptoms (increase of 1 year: adjusted hazard ratio, 1.1; 95% confidence interval, 1.0-1.1; P<.005) were associated with composite surgical failure, where rates of failure were 2.9 and 1.8 times higher in women with obesity and women who are overweight than women who have normal weight and women who are underweight (95% confidence intervals, 1.5-5.8 and 0.9-3.5) and 3.0 times higher in women experiencing >5 years prolapse symptoms than women experiencing ≤5 years prolapse symptoms (95% confidence interval, 1.8-5.0). Sacrospinous hysteropexy with graft had a lower rate of failure than hysterectomy with uterosacral suspension (adjusted hazard ratio, 0.6; 95% confidence interval, 0.4-1.0; P=.05). The interaction between symptom duration and apical repair (P=.07) indicated that failure was less likely after hysteropexy than hysterectomy for those with ≤5 years symptom duration (adjusted hazard ratio, 0.5; 95% confidence interval, 0.2-0.9), but not for those with >5 years symptom duration (adjusted hazard ratio, 1.0; 95% confidence interval 0.5-2.1)., Conclusion: Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Importance: Although transient voiding dysfunction is common after surgical correction of pelvic organ prolapse, it has not been well studied in women undergoing colpocleisis., Objective: This study aimed to identify characteristics associated with discharge home with a urinary catheter in women undergoing colpocleisis., Study Design: This is a secondary analysis of a multicenter prospective study examining the effect of pelvic support, symptoms, and satisfaction in women undergoing colpocleisis. Publicly accessible deidentified data sets of the index study were analyzed. Primary outcome was discharge with a urinary catheter postoperatively. Characteristics associated with discharge with catheter after colpocleisis were assessed via logistic regression. Covariates were selected based on statistical significance at 0.05 and clinical relevance on bivariate analysis., Results: Of the 136 women (mean age, 77.8 ± 5.5 years) undergoing colpocleisis in the index study, 68 (50.0%) were discharged with catheter. Baseline characteristics did not differ, except that the catheter group had lower prior incontinence surgery (7.4% vs 22.1%, P = 0.02) and higher preoperative postvoid residual volume (PVR; 189.8 ± 187.6 vs 91.3 ± 124.2 mL, P < 0.01). Those discharged with catheter had greater estimated blood loss (128.7 ± 88.5 vs 95.3 ± 74.5 mL, P = 0.02), operative time (125.2 ± 56.3 vs 100.8 ± 45.4 minutes, P < 0.01), and concomitant levator myorrhaphy (82.4% vs 58.8%, P < 0.01). Multivariable analysis revealed preoperative PVR (adjusted odds ratio, 1.2; 95% confidence interval, 1.0-1.4 for every 50-mL increase in PVR) and levator myorrhaphy (adjusted odds ratio, 4.3; 95% confidence interval, 1.6-11.3) were associated with postoperative catheterization., Conclusions: In women undergoing colpocleisis, higher preoperative PVR and levator myorrhaphy were associated with discharge with catheter., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)

Objectives: There does not currently exist a complication scale to evaluate pelvic reconstructive surgery (PRS) that takes in account patient-centered outcomes. The purpose of this study was to characterize and compare patient and surgeon responses to a simplified, patient-centered version of the previously described Pelvic Floor Complication Scale (PFCS)., Methods: This is a multicenter (4 female pelvic medicine and reconstructive surgery practices) cross-sectional study of patients and surgeons. Using focus groups and telephone surveys, the original PFCS questionnaire was simplified. One hundred and twenty-four patients were recruited 6-12 months after PRS. Fifty-seven surgeons were recruited via electronic questionnaires. Surgeons and patients were asked to rank the severity and bother of each complication on a scale of 0 to 5 (0, none; 1, mild; 3, moderate; 5, major)., Results: Patients rated bother higher than severity for 36 of 38 complications (all differences ≤0.5 points). For statistical analysis, the highest response to patient bother/severity was chosen to weigh in favor of the patient. Patient bother/severity scores were significantly different (±0.5 points) for 27 of 38 complications compared with surgeon responses. Surgeon scores were higher for 5 complications (0.5-1.9 point differences) related to major injury requiring repair and wound breakdown. Patient scores were higher for 22 complications with the highest differences related to dyspareunia, constipation, or new/persistent urinary incontinence., Conclusions: This mixed methods investigation revealed key differences between how patients and surgeons value PRS complications. Surgeons scored major surgical injuries higher than patients, whereas patients rated issues that many surgeons consider quality-of-life outcomes higher due to potential long-term bother. These data will be used to create a simplified, patient-centered PFCS., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2021 American Urogynecologic Society. All rights reserved.)

Introduction and Hypothesis: The objective was to determine the relationship between the preoperative D-point and apical outcomes at 24 months, using the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) dataset., Methods: This was a secondary analysis of the OPTIMAL trial, a randomized multi-centered study comparing outcomes of sacrospinous ligament fixation and transvaginal uterosacral ligament suspension (USLS). The 2-year dataset utilized included women undergoing USLS with concomitant hysterectomy. The primary outcome was the relationship between preoperative D-point and apical outcomes at 24 months. Secondary objectives were to determine the relationship between preoperative D-point and anatomical, composite and subjective outcomes, and to determine a D-point cut-off that could be used to predict success in each of these categories., Results: Of the 186 women in the USLS arm, 120 were available for analysis of anatomical failure at 24 months. A higher preoperative D-point correlated with improved apical outcome (C-point) at 24 months (r = 0.34; p value = 0.0002). Using ROC curves, a moderate association was found between the preoperative D-point and apical and anatomical success, (AUC 0.689 and 0.662). There was no relationship between preoperative D-point and composite or subjective success (AUC 0.577 and 0.458). Based on the ROC curves, a "cut-off" D-point value of -4.25 cm (sensitivity = 0.58, specificity = 0.67) was determined to be a predictor of postoperative anatomical success at 2 years., Conclusions: Preoperative D-point correlates with postoperative anatomical and apical support, but is less successful at predicting subjective outcomes. The strongest predictive D-point cut-off for anatomical and apical success at 24 months was -4.25 cm., (© 2021. The International Urogynecological Association.)

Introduction and Hypothesis: The protocol and analysis methods for the Defining Mechanisms of Anterior Vaginal Wall Descent (DEMAND) study are presented. DEMAND was designed to identify mechanisms and contributors of prolapse recurrence after two transvaginal apical suspension procedures for uterovaginal prolapse., Methods: DEMAND is a supplementary cohort study of a clinical trial in which women with uterovaginal prolapse randomized to (1) vaginal hysterectomy with uterosacral ligament suspension or (2) vaginal mesh hysteropexy underwent pelvic magnetic resonance imaging (MRI) at 30-42 months post-surgery. Standardized protocols have been developed to systematize MRI examinations across multiple sites and to improve reliability of MRI measurements. Anatomical failure, based on MRI, is defined as prolapse beyond the hymen. Anatomic measures from co-registered rest, maximal strain, and post-strain rest (recovery) sequences are obtained from the "true mid-sagittal" plane defined by a 3D pelvic coordinate system. The primary outcome is the mechanism of failure (apical descent versus anterior vaginal wall elongation). Secondary outcomes include displacement of the vaginal apex and perineal body and elongation of the anterior wall, posterior wall, perimeter, and introitus of the vagina between (1) rest and strain and (2) rest and recovery., Results: Recruitment and MRI trials of 94 participants were completed by May 2018., Conclusions: Methods papers which detail studies designed to evaluate anatomic outcomes of prolapse surgeries are few. We describe a systematic, standardized approach to define and quantitatively assess mechanisms of anatomic failure following prolapse repair. This study will provide a better understanding of how apical prolapse repairs fail anatomically.

Objective: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP., Methods: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification., Conclusions: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications., Competing Interests: E.E. receives grant funding from NIH/National Center for Advancing Translational Sciences NCATS KL2TR001088; S.M. receives honoraria from UpToDate is a board member of the American Urogynecologic Society; Y.M.K. receives grant funding and salary supported by National Institutes of Health (NIH)/National Center for Complementary and Integrative Health R01AT007171; C.A.F. receives unrestricted research grants from Coloplast, Inc, and Caldera, Inc, and royalties from UpToDate, Inc; D.D.R. receives grant funding and investigator-initiated research with Pfizer (study drug provided by company), R01 AG047290; D.M. is a government employee (NIH/NICHD); H.E.R. receives grant funding from NICHD/National Institute on Aging and Pelvalon, is consultant to Pelvalon, Bluewind, and Renovia, receives royalties from Up to Date, and is board member of the Society of Gynecologic Surgeons, World Wide Fistula Fund. The other authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Objectives: To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair., Methods: Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence., Results: Recruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit., Conclusions: This trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

Objectives: The primary objective of this study is to compare patient versus physician rankings of adverse event (AE) and adverse symptom (AS) severity after pelvic reconstructive surgery. Secondary objectives include to estimate the association between patient rankings of AEs/ASs with decision-making and quality-of-life outcomes and to determine whether patient perspective about AE/AS changes over time., Methods: This is a supplementary study, Patient-Perspectives in Adverse Event Reporting (PPAR), to the index trial, ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design). During the trial, AEs/ASs will be assessed by physicians longitudinally every 6 months, which includes a determination of the AE/AS grade severity. For PPAR, additional patient perspective will be measured for 19 predetermined AEs/ASs at the time of identification and again at 12 and 36 months postoperatively. Decision-making and quality-of-life questionnaires will be collected at these time points. The primary outcome, the overall interrater agreement between patient and physician rankings for AE/AS severity, will be determined using a repeated-measures concordance correlation coefficient., Results: To date, the index trial has completed enrollment, and follow-up is ongoing., Conclusions: The PPAR methods for incorporating patient perspective in the measurement of AEs/ASs to determine their agreement with physician ranking, long-term relevance, and impact on treatment decision making and quality of life are described. This will contribute to improved measurements of AEs/ASs in future research with the goal of improving patient counseling and informing expectations and treatment decision making., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2020 American Urogynecologic Society. All rights reserved.)

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.

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.

Objective: The objective of this study was to present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe), which compares the efficacy and safety of 3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy., Methods: Patient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/benefits of each technique, a noninferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the 2 mesh repairs to NT transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen), and no prolapse retreatment, with a minimum follow-up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function., Results: Randomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase., Conclusions: This report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus NT apical repairs.

Objectives: The aim of this study was to investigate the association between urinary phytoestrogen levels with symptoms of pelvic organ prolapse (POP) and fecal incontinence (FI) in postmenopausal women., Methods: This is a cross-sectional study using the National Health and Nutrition Examination Survey database from 2005 to 2010 including postmenopausal women 40 years or older who either had both ovaries removed and/or had no period in the past year due to hysterectomy and/or menopause. Urinary concentrations of 6 phytoestrogens were measured. Pelvic organ prolapse symptoms were defined as a positive response to the question, "Do you see or feel a bulge in the vaginal area?" Fecal incontinence was defined as leakage of mucus, liquid, or solid stool occurring at least monthly. Using appropriate sample weights, prevalence estimates and 95% confidence intervals were calculated. Logistic regression was performed assessing associations between pelvic floor symptoms and log-transformed phytoestrogen levels adjusting for appropriate covariates., Results: Participants included 1341 postmenopausal women with phytoestrogen data; 1213 with or without POP symptoms and 1221 with or without FI symptoms. Multivariable analysis revealed no association of urinary phytoestrogen levels with POP symptoms. Higher urinary O-desmethylangolensin level was associated with decreased odds of FI symptoms in postmenopausal women (adjusted odds ratio, 0.92; 95% confidence interval, 0.86-0.99)., Conclusions: Increased urinary O-desmethylangolensin level was associated with lower odds of FI. Future research may be warranted to further investigate the potential of specific phytoestrogens as mediators of FI, as well as the role of phytoestrogens on POP symptoms.

Background: Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research., Objective: To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP)., Materials and Methods: This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale "somewhat better" vs "no change") and distribution-based methods., Results: The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13-0.61) and SRM (0.13-0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r = 0.41; n = 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r = 0.09-0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates., Conclusion: The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction and Hypothesis: We compared treatment success and adverse events between women undergoing open abdominal sacrocolpopexy (ASC) vs vaginal repair (VAR) using data from women enrolled in one of three multicenter trials. We hypothesized that ASC would result in better outcomes than VAR., Methods: Participants underwent apical repair of stage 2-4 prolapse. Vaginal repair included uterosacral, sacrospinous, and iliococcygeal suspensions; sacrocolpopexies were via laparotomy. Success was defined as no bothersome bulge symptoms, no prolapse beyond the hymen, and no retreatment up to 24 months. Adverse events were collected at multiple time points. Outcomes were analyzed using longitudinal mixed-effects models to obtain valid outcome estimates at specific visit times, accounting for data missing at random. Comparisons were controlled for center, age, body mass index (BMI), initial Pelvic Organ Prolapse Quantification (POP-Q) stage, baseline scores, prior prolapse repair, and concurrent repairs., Results: Of women who met inclusion criteria (1022 of 1159 eligibile), 701 underwent vaginal repair. The ASC group (n = 321) was older, more likely white, had prior prolapse repairs, and stage 4 prolapse (all p < 0.05). While POP-Q measurements and symptoms improved in both groups, treatment success was higher in the ASC group [odds ratio (OR) 6.00, 95% confidence interval (CI) 3.45-10.44). The groups did not differ significantly in most questionnaire responses at 12 months and overall improvement in bowel and bladder function. By 24 months, fewer patients had undergone retreatment (2% ASC vs 5% VAR); serious adverse events did not differ significantly through 6 weeks (13% vs 5%, OR 2.0, 95% CI 0.9-4.7), and 12 months (26% vs 13%, OR 1.6, 95% CI 0.9-2.9), respectively., Conclusions: Open sacrocolpopexy resulted in more successful prolapse treatment at 2 years.

Introduction and Hypothesis: The objective was to prospectively characterize dynamic pelvic 3-Tesla magnetic resonance imaging (dp3T MRI) findings in nulligravida women and characterize changes 6 months after delivery in the same woman., Methods: In this prospective study, nulligravida women seeking assisted reproductive technology for pregnancy were recruited. After physical examination by Pelvic Organ Prolapse Quantification (POP-Q), Brink assessment and measures including the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7, pre-pregnancy dp3T MRI at rest, with strain, and evacuation were performed. Assessments were repeated ≥6 months postpartum. Analysis included Welch and paired t tests for continuous variables, Fisher's exact test for differences in categorical outcomes, and paired t tests for postpartum symptoms., Results: Nineteen subjects (mean ± SD age, 31 ± 5 years) completed baseline clinical and dp3T MRI studies, 15 delivered and 10 (30.5 ± 3 years) completed pre-pregnancy and post-delivery clinical and dp3T MRI assessments. There were no significant changes in scores of validated questionnaires (all p > 0.05) or on POP-Q measures post-delivery. Two (20%) subjects without pre-pregnancy levator tears had tears on MRI post-delivery. MRI measures of pelvic organ descent were increased post-delivery. Seventeen pelvic soft-tissue parameters increased by greater than 10% post-delivery, including 5 out of 70 (7.1%), 17 out of 110 (15.5%), and 50 out of 110 (45.5%) values exceeding thresholds at rest, strain, and evacuation respectively., Conclusions: Dynamic pelvic 3T MRI detected levator tears and increased pelvic organ descent, which can be directly attributed to pregnancy and delivery.

Pelvic organ prolapse (POP), downward descent of the pelvic organs resulting in a protrusion of the vagina, is a highly prevalent condition, responsible for 300,000 surgeries in the U.S. annually. Rectocele, a posterior vaginal wall (PVW) prolapse of the rectum, is the second most common type of POP after cystocele. A rectocele usually manifests itself along with other types of prolapse with multicompartment pelvic floor defects. To date, the specific mechanics of rectocele formation are poorly understood, which does not allow its early stage detection and progression prediction over time. Recently, with the advancement of imaging and computational modeling techniques, a plethora of finite element (FE) models have been developed to study vaginal prolapse from different perspectives and allow a better understanding of dynamic interactions of pelvic organs and their supporting structures. So far, most studies have focused on anterior vaginal prolapse (AVP) (or cystocele) and limited data exist on the role of pelvic muscles and ligaments on the development and progression of rectocele. In this work, a full-scale magnetic resonance imaging (MRI) based three-dimensional (3D) computational model of the female pelvic anatomy, comprising the vaginal canal, uterus, and rectum, was developed to study the effect of varying degrees (or sizes) of rectocele prolapse on the vaginal canal for the first time. Vaginal wall displacements and stresses generated due to the varying rectocele size and average abdominal pressures were estimated. Considering the direction pointing from anterior to posterior side of the pelvic system as the positive Y-direction, it was found that rectocele leads to negative Y-direction displacements, causing the vaginal cross section to shrink significantly at the lower half of the vaginal canal. Besides the negative Y displacements, the rectocele bulging was observed to push the PVW downward toward the vaginal hiatus, exhibiting the well-known "kneeling effect." Also, the stress field on the PVW was found to localize at the upper half of the vaginal canal and shift eventually to the lower half with increase in rectocele size. Additionally, clinical relevance and implications of the results were discussed.

Objective: Our objective was to evaluate 30-day readmission, 12-month prolapse recurrence, and complications after apical surgeries in older women., Methods: A retrospective cohort study was conducted using 2002-2011 Medicare data in women 65 years or older who underwent abdominal sacrocolpopexy with synthetic mesh, vaginal uterosacral, or sacrospinous colpopexy with 12 months follow-up. Vaginal mesh procedures were excluded. The primary outcome was 30-day inpatient readmission. Secondary outcomes were complications and prolapse recurrence, defined as either reoperation or pessary insertion. We used Pearson χ, Fisher exact tests, and analyses of variance to examine difference between surgical treatment groups. Odds ratios (ORs) utilizing Charlson Comorbidity Index, age, race, and procedure type were calculated to assess the differences in the outcomes probability., Results: Of 3,015 women, 863 underwent abdominal sacrocolpopexy, 510-uterosacral and 1,642-sacrospinous ligament suspensions. The 30-day readmission was 7.4% (95% confidence interval [CI] 5.7-9.2%; OR 2.4, 95% CI 1.7-3.5, P<.01) after abdominal sacrocolpopexy and 4.5% (95% CI 2.7-6.3%; OR 1.3, 95% CI 0.8-2.1, P=.3) after uterosacral compared with 3.5% (95% CI 2.6-4.4% P<.01) after sacrospinous ligament suspensions. Prolapse recurrence did not differ between the groups (8.2%, 95% CI 6.4-10.1%; 10.6%, 95% CI 7.9-13.3%; and 9.9%, 95% CI 8.4-11.3%, P=.3, respectively). Women had 30-day gastrointestinal complications (6.1%, 95% CI 4.5-7.7%; 1.2%, 95% CI 0.2-2.1%; and 1.1%, 95% CI 0.6-1.6%, P<.01), surgical site infections (5.9%, 95% CI 4.3-7.5%; 3.1%, 95% CI 1.6-4.7%; and 3.7%, 95% CI 2.8-4.6%, P=.01), genitourinary complications (10.9%, 95% CI 8.8-13%; 17.7%, 95% CI 14.3-21%; and 13.6%, 95% CI 12-15.3%, P<.01), and medical complications (7.4%, 95% CI 5.7-9.2%; 7.8%, 95% CI 5.5-10.2%; and 4.4%, 95% CI 3.4-5.4%, P<.01; all after abdominal sacrocolpopexy, uterosacral, and sacrospinous ligament suspensions, respectively)., Conclusion: Vaginal apical suspensions compared with abdominal sacrocolpopexy with synthetic mesh are associated with lower rates of postoperative 30-day readmission without an increase in prolapse recurrence among older women., Competing Interests: The other authors did not report any potential conflicts of interest.

Treatment of anterior vaginal prolapse (AVP), suffered by over 500,000 women in the USA, is a challenge in urogynecology because of the poorly understood mechanics of AVP. Recently, computational modeling combined with finite element method has been used to model AVP through the study of pelvic floor muscle and connective tissue impairments on the anterior vaginal wall (AVW). Also, the effects of pelvic organ displacements on the AVW were studied numerically. In our current work, an MRI-based full-scale biofidelic computational model of the female pelvic system composed of the urinary bladder, vaginal canal, and the uterus was developed, and a novel finite element method framework was employed to simulate vaginal tissue stiffening and also bladder filling due to expansion for the first time. A mesh convergence study was conducted to choose a computationally efficient mesh, and a non-linear hyperelastic Yeoh's material model was adopted for the study. The AVW displacements, mechanical stresses, and strains were estimated at varying degrees of bladder fills and vaginal tissue stiffening. Both bladder filling and vaginal stiffening were found to increase the stress concentration on the AVW with varying trends, which have been discussed in detail in the paper. To our knowledge, this study is the first to estimate the individual and combined effects of bladder filling and vaginal tissue stiffening due to prolapse on the AVW. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Objectives: The objective of this study was to characterize symptom prevalence, awareness of pelvic floor disorders (PFDs) in family/friends, and understanding of factors contributing to the development of PFDs in women aged 19 to 30 years., Methods: This study is a cross-sectional study via online questionnaire survey of female students aged 19 to 30 years enrolled at the University of Alabama at Birmingham. Results of "adolescent women" aged 19 to 24 years were compared with "young women" aged 25 to 30 years., Results: A total of 1092 questionnaires were completed with the mean age being 23.5 ± 3.1 years. The overall rate of urinary incontinence (UI) was 10.3% without a difference between adolescent and young women (P = 0.61). There were no differences in rates of urgency UI (P = 0.061), stress UI (P = 0.29), or pelvic organ prolapse (POP) symptoms (P = 0.56) between groups. There was no difference between groups in awareness of family members with UI, fecal incontinence (FI), or POP symptoms (P ≥ 0.24). However, logistic regression showed that the young women were more likely to have received education regarding UI (adjusted odds ratio [aOR], 2.6; 95% confidence interval [CI], 1.8-3.6), FI (aOR, 3.3; 95% CI, 2.2-4.8), POP (aOR, 2.9; 95% CI, 2.1-4.2), and have greater understanding regarding causes of UI (aOR, 2.9; 95% CI, 1.7-4.8), FI (aOR, 1.6; 95% CI, 1.1-2.3), and POP (aOR, 1.9; 95% CI, 1.3-2.9)., Conclusions: Women aged 25 to 30 years had more awareness and understanding of PFDs compared with adolescent women. These data may have implications for primary prevention strategies of PFDs., Competing Interests: The authors did not report any other disclosures or potential conflicts of interest.

Objectives: To characterize the association between thoracic (T) and lumbar (L) spinal curvature and pelvic floor (PF) symptoms (pelvic organ prolapse, urinary incontinence [UI], fecal incontinence [FI])., Methods: Of women undergoing a bone mineral density scan from January 2007 to October 2010, patients who completed PF symptom questionnaires and had T and/or L spine radiographs or computed tomography examinations within 3 years of questionnaire completion were included in this study. The spine angles were measured using the Cobb angle method. The T and L curvatures were categorized as hypokyphosis (<20°), normal T kyphosis (20-40°), hyperkyphosis (>40°), hypolordosis (<40°), normal L lordosis (40-70°), and hyperlordosis (>70°). The presence and type of UI were identified with the 3 Incontinence Questionnaire and FI with the Modified Manchester Questionnaire. Pelvic organ prolapse was defined as a positive response to the presence of a bulge question from the PF Distress Inventory-20., Results: Of 1665 eligible women, 824 and 302 (mean age 64 ± 10 for both) had T and L spine images, respectively. No differences in PF symptoms were observed in the T or L spine groups categorized by hypo-, normal, and hyperkyphosis/lordosis except for urgency UI being more prevalent in the hypolordosis group (P = 0.01). However, upon further characterization using logistic regression, no association was noted between PF symptoms and T or L spine angles; no differences in the mean angles were found between women with versus without PF symptoms (P ≥ 0.05)., Conclusions: The current study shows that the T and L spinal curvatures are not associated with the presence of PF symptoms.

Background: Functional status plays an important role in the comprehensive characterization of older adults. Functional limitations are associated with an increased risk of adverse treatment outcomes, but there are limited data on the prevalence of functional limitations in older women with pelvic floor disorders., Objective: The aim of the study was to describe the prevalence of functional limitations based on health status in older women with pelvic organ prolapse (POP)., Study Design: This pooled, cross-sectional study utilized data from the linked Health and Retirement Study and Medicare files from 1992 through 2008. The analysis included 890 women age ≥65 years with POP. We assessed self-reported functional status, categorized in strength, upper and lower body mobility, activities of daily living (ADL), and instrumental ADL (IADL) domains. Functional limitations were evaluated and stratified by respondents self-reported general health status. Descriptive statistics were used to compare categorical and continuous variables, and logistic regression was used to measure differences in the odds of functional limitation by increasing age., Results: The prevalence of functional limitations was 76.2% in strength, 44.9% in upper and 65.8% in lower body mobility, 4.5% in ADL, and 13.6% in IADL. Limitations were more prevalent in women with poor or fair health status than in women with good health status, including 91.5% vs 69.9% in strength, 72.9% vs 33.5% in upper and 88.0% vs 56.8% in lower body mobility, 11.6% vs 0.9% in ADL, and 30.6% vs 6.7% in IADL; all P < .01. The odds of all functional limitations also increased significantly with advancing age., Conclusion: Functional limitations, especially in strength and body mobility domains, are highly prevalent in older women with POP, particularly in those with poor or fair self-reported health status. Future research is necessary to evaluate if functional status affects clinical outcomes in pelvic reconstructive and gynecologic surgery and whether it should be routinely assessed in clinical decision-making when treating older women with POP., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: This study aimed to assess trends and factors affecting inpatient hospital costs and length of stay (LOS) in surgical treatment of pelvic organ prolapse in the United States., Methods: A retrospective cross-sectional study along with longitudinal trend analysis from the 2001 to 2011 National Inpatient Sample included subjects who underwent inpatient prolapse repairs. The primary outcomes were inpatient mean cost per admission and LOS. We compared unadjusted differences in primary outcomes for each patient and hospital characteristic using 2011 data with analysis of variance. Multivariable regression estimated proportional change in cost and LOS associated with each characteristic., Results: Unadjusted analysis revealed increased LOS with age of 80 years or older, African American race, uninsured status, lower income, and lower surgical volume hospitals (≤75%) as well as increased costs in the West and public hospitals. On multivariable analyses, African Americans had 1.09 (95% confidence interval [CI], 1.05-1.13; P < 0.001) times longer LOS compared with Caucasians, and the uninsured had 1.15 (95% CI, 1.01-1.30; P = 0.032) times longer LOS compared with those privately insured. Comorbidities associated with 20% increase in LOS and costs were pulmonary circulation disorders, metastatic cancer, weight loss, coagulopathy, and electrolyte/fluid imbalance (P < 0.001). Congestive heart failure and blood loss/deficiency anemia lead to 20% longer LOS (P < 0.001). In 2001-2011, mean LOS declined from 2.42 days (95% CI, 2.37-2.47) to 1.79 days (95% CI, 1.71-1.87) (P < 0.001), whereas mean total cost increased from $6233 (95% CI, $5859-$6607) to $9035 (95% CI, $8632-$9438) (P < 0.001)., Conclusions: Inpatient surgical costs for prolapse increased despite decreasing LOS. Some patient and hospital characteristics are associated with increased inpatient costs and LOS.

Objectives: To characterize pain and exposure after Prolift placement and identify risk factors., Methods: A case series of women who underwent Prolift vaginal mesh were surveyed. Pain was assessed using a visual analog scale. Exposure was evaluated clinically., Results: Of 183 eligible patients, 160 completed the survey, and 45 returned for examination. Mean preoperative pain score was 0.97 and postoperative was 1.35 (P = 0.12). Pre- and postoperative pain scores by compartment were: anterior (1.34 vs 1.25, mean change -0.09, P = 0.84), posterior (1.30 vs 1.56, mean change 0.26, P = 0.72), and total (0.63 vs 1.34, mean change 0.71, P = 0.05). Graft exposure was confirmed in 23 of 183 patients (12.6%); however, because asymptomatic patients were not examined, the true exposure rate may be underestimated. Hematoma formation is independently associated with mesh exposure, adjusted odds ratio 18.4 (95% confidence interval 3.4-147.4, P = 0.01)., Conclusions: Although pain scores did not increase overall, there was a trend toward increased pain score in the patients with total (anterior and posterior) Prolift. Hematoma formation was significantly associated with mesh exposure.

Objectives: The objective of this study was to describe posterior prolapse (pPOP) and obstructed defecation (OD) symptoms 5 years after open abdominal sacrocolpopexy (ASC)., Methods: We grouped the extended colpopexy and urinary reduction efforts trial participants with baseline and 5-year outcomes into 3 groups using baseline posterior Pelvic Organ Prolapse Quantification (POP-Q) points and concomitant posterior repair (PR) (no PR, Ap <0; no PR, Ap ≥0; and +PR). Posterior colporrhaphy, perineorrhaphy, or sacrocolpoperineopexy were included as PR, which was performed at surgeon's discretion. Outcomes were dichotomized into presence/absence of pPOP (Ap ≥0) and OD symptoms (≥2 on 1 or more questions about digital assistance, excessive straining, or incomplete evacuation). Composite failure was defined by both pPOP and OD symptoms or pPOP reoperation., Results: Ninety participants completed baseline and 5-year outcomes or were retreated with mean follow-up of 7.1 ± 1.0 years. Of those with no PR (Ap <0), 2 women (2/36; 9%) developed new pPOP with OD symptoms; 1 underwent subsequent PR. Nearly all (23/24; 96%) with no PR (Ap ≥0) demonstrated sustained resolution of pPOP, and none underwent PR. Fourteen percent (4/29) of +PR underwent repeat PR within 5 years, and 12% had recurrent pPOP. Regardless of PR, OD symptoms improved in all groups after ASC, although OD symptoms were still present in 17% to 19% at 5 years., Conclusions: Symptomatic pPOP is common 5 years after ASC regardless of concomitant PR. Obstructed defecation symptoms may improve after ASC regardless of PR. Recurrent pPOP and/or reoperation was highest among those who received concomitant PR at ASC. Further studies identifying criteria for concomitant PR at the time of ASC are warranted.

Objective: To construct and validate a prediction model for estimating the risk of de novo stress urinary incontinence (SUI) after vaginal pelvic organ prolapse (POP) surgery and compare it with predictions using preoperative urinary stress testing and expert surgeons' predictions., Materials and Methods: Using the data set (n=457) from the Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial, a model using 12 clinical preoperative predictors of de novo SUI was constructed. De novo SUI was determined by Pelvic Floor Distress Inventory responses through 12 months postoperatively. After fitting the multivariable logistic regression model using the best predictors, the model was internally validated with 1,000 bootstrap samples to obtain bias-corrected accuracy using a concordance index. The model's predictions were also externally validated by comparing findings against actual outcomes using Colpopexy and Urinary Reduction Efforts trial patients (n=316). The final model's performance was compared with experts using a test data set of 32 randomly chosen Outcomes Following Vaginal Prolapse Repair and Midurethral Sling trial patients through comparison of the model's area under the curve against: 1) 22 experts' predictions; and 2) preoperative prolapse reduction stress testing., Results: A model containing seven predictors discriminated between de novo SUI status (concordance index 0.73, 95% confidence interval [CI] 0.65-0.80) in Outcomes Following Vaginal Prolapse Repair and Midurethral Sling participants and outperformed expert clinicians (area under the curve 0.72 compared with 0.62, P<.001) and preoperative urinary stress testing (area under the curve 0.72 compared with 0.54, P<.001). The concordance index for Colpopexy and Urinary Reduction Efforts trial participants was 0.62 (95% CI 0.56-0.69)., Conclusion: This individualized prediction model for de novo SUI after vaginal POP surgery is valid and outperforms preoperative stress testing, prediction by experts, and preoperative reduction cough stress testing. An online calculator is provided for clinical use., Level of Evidence: III.

Objective: To estimate the prevalence and trends of these pelvic floor disorders in U.S. women from 2005 to 2010., Methods: We used the National Health and Nutritional Examination Survey from 2005-2006, 2007-2008, and 2009-2010. A total of 7,924 nonpregnant women (aged 20 years or older) were categorized as having: urinary incontinence (UI)-moderate to severe (3 or higher on a validated UI severity index, range 0-12); fecal incontinence-at least monthly (solid, liquid, or mucus stool); and pelvic organ prolapse-seeing or feeling a bulge. Potential risk factors included age, race and ethnicity, parity, education, poverty income ratio, body mass index ([BMI] less than 25, 25-29, 30 or greater), comorbidity count, and reproductive factors. Using appropriate sampling weights, weighted χ analysis and multivariable logistic regression models with odds ratios and 95% confidence intervals (95% CIs) were reported., Results: The weighted prevalence rate of one or more pelvic floor disorders was 25.0% (95% CI 23.6-26.3), including 17.1% (95% CI 15.8-18.4) of women with moderate-to-severe UI, 9.4% (95% CI 8.6-10.2) with fecal incontinence, and 2.9% (95% CI 2.5-3.4) with prolapse. From 2005 to 2010, no significant differences were found in the prevalence rates of any individual disorder or for all disorders combined (P>.05). After adjusting for potential confounders, higher BMI, greater parity, and hysterectomy were associated with higher odds of one or more pelvic floor disorders., Conclusion: Although rates of pelvic floor disorders did not change from 2005 to 2010, these conditions remain common, with one fourth of adult U.S. women reporting at least one disorder., Level of Evidence: III.

Women are seeking care for pelvic organ prolapse in increasing numbers and a significant proportion of them will undergo a second repair for recurrence. This has initiated interest by both surgeons and industry to utilize and design prosthetic mesh materials to help augment longevity of prolapse repairs. Unfortunately, the introduction of transvaginal synthetic mesh kits for use in women was done without the benefit of level 1 data to determine its utility compared with native tissue repair. This report summarizes the potential benefit/risks of transvaginal synthetic mesh use for pelvic organ prolapse and recommendations regarding its continued use.

Importance: More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness., Objectives: To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy)., Design, Setting, and Participants: Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years., Main Outcomes and Measures: Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index., Results: By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%)., Conclusions and Relevance: During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion., Trial Registration: clinicaltrials.gov Identifier: NCT00099372.

Objective: The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women randomized to pessary versus behavioral therapy for treatment of stress urinary incontinence (SUI)., Methods: Change in symptom and condition-specific health-related quality-of-life (HRQOL) measures were compared between pessary and behavioral groups 3 months after randomization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial. Four hundred forty-six women with symptoms of SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies) or combination therapy. Validated measures utilized included urinary, prolapse, and colorectal scales of the Pelvic Floor Distress Inventory; urinary, prolapse, and colorectal scales of the Pelvic Floor Impact Questionnaire; and Stress and Urge scales of the Questionnaire for Urinary Incontinence Diagnosis. Student t test and analysis of variance were used to compare scores within and between groups., Results: Mean age of participants was 49.8 (SD, 11.9) years; 84% were white, and 10% were African American. One hundred forty-nine were randomized to pessary, and 146 to behavioral therapy. Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after randomization, but there was no statistically significant difference between groups., Conclusions: There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI. Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI.

Objective: The objective of this study was to estimate the association between body mass index (BMI) and pelvic organ prolapse symptoms and bother among overweight and obese women with urinary incontinence before and after weight loss., Methods: Women (N = 338) were randomized to either an intensive 6-month weight loss or educational program (control); they were evaluated for prolapse symptoms at baseline and 6 months. Symptomatic prolapse was defined as a positive response to at least 1 prolapse subscale question of the Urogenital Distress Inventory. "Bother" was defined as responses of slight, moderate, or great. Women with prolapse symptoms were analyzed by baseline BMI category: overweight, obese, and severely obese at baseline and at 6 months. Proportional odds regression and χ tests for trend were used for analysis., Results: Age mean was 53 (SD, 10) years, BMI mean was 36 (SD, 6) kg/m, and 78% were white. A higher proportion of obese women reported feeling vaginal bulging compared with overweight women (13% vs 0%, P = <0.01). At baseline, 37% (n = 124) reported bothersome "lower abdominal pressure"; 18% (n = 62), bothersome "heaviness in the pelvic area"; and 14% (n = 48), bothersome "pelvic discomfort when standing." Nine percent (n = 31) reported bothersome "feeling," and 2% (n = 6) reported bothersome "seeing a bulge" in the vagina. At 6 months, there were no significant differences in improvement of self-reported bothersome prolapse symptoms in women in the weight loss or the control group., Conclusions: In this study of overweight and obese women, increasing BMI was associated with only "feeling" a vaginal bulge. Weight loss did not improve bothersome prolapse symptoms.

Introduction and Hypothesis: This study describes pelvic organ support after childbirth., Methods: This ancillary analysis of the Childbirth and Pelvic Symptoms Imaging Study compares pelvic organ prolapse quantification 6-12 months after childbirth among three cohorts of primiparous women: vaginal delivery with sphincter tear (n = 106), vaginal delivery without sphincter tear (n = 108), and cesarean without labor (n = 39)., Results: Of participants, 31.2% had stage II support. Prolapse to or beyond the hymen was present in 14% after vaginal delivery with sphincter tear (95% confidence interval 8%, 22%), 15% (9%, 24%) after vaginal delivery without sphincter tear, and 5% (1%, 17%) after cesarean without labor (p = 0.23). A study of 132 women per group would be required for 80% power to test differences between 5% and 15%., Conclusions: While these data provide insufficient power to dismiss a difference in pelvic organ support between modes of delivery, they add to our understanding of support following childbirth.

BackgroundProlapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies.ObjectiveThis study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse.Study designThis multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests.ResultsOf the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15).ConclusionThe primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.

Pelvic floor disorders affect up to 24% of adult women in the United States, and many patients with pelvic organ prolapse (POP) choose to undergo surgical repair to improve their quality of life. While a variety of surgical repair approaches and techniques are utilized, including mesh augmentation, there is limited comparative effectiveness and safety outcome data guiding best practice. In conjunction with device manufacturers, federal regulatory organizations, and professional societies, the American Urogynecologic Society developed the Pelvic Floor Disorders Registry (PFDR) designed to improve the quality of POP surgery by facilitating quality improvement and research on POP treatments. The PFDR will serve as a resource for surgeons interested in benchmarking and outcomes data and as a data repository for Food and Drug Administration-mandated POP surgical device studies. Provider-reported clinical data and patient-reported outcomes will be collected prospectively at baseline and for up to 3 years after treatment. All data elements including measures of success, adverse events, and surgeon characteristics were identified and defined within the context of the anticipated multifunctionality of the registry, and with collaboration from multiple stakeholders. The PFDR will provide a platform to collect high-quality, standardized patient-level data from a variety of nonsurgical (pessary) and surgical treatments of POP and other pelvic floor disorders. Data from this registry may be used to evaluate short- and longer-term treatment outcomes, patient-reported outcomes, and complications, as well as to identify factors associated with treatment success and failure with the overall goal of improving the quality of care for women with these conditions.