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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. Marks 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

BackgroundUnderstanding 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.MethodsThis 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.ResultsThis 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).ConclusionsMany 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.

ObjectivesThe objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence.MethodsThis is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model.ResultsWomen receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]).ConclusionsA higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.

Introduction and hypothesisLimited 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.MethodsThis 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.ResultsSuccess 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.ConclusionsSurgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims: To compare surgical success rates in older versus younger women a minimum of 3 years post transvaginal native tissue repair for apical prolapse. Post‐operative symptom severity and quality of life improvement, surgical complications and retreatment were also examined. Methods: Women who underwent transvaginal native tissue repair for apical prolapse between 2011 and 2013 were eligible. Subjects completed the pelvic floor distress inventory (PFDI‐20), pelvic floor impact questionnaire (PFIQ‐7), and patient global impression of improvement (PGI‐I), and were categorized as "younger" (age <70) or "older" (age ≥70). The primary outcome of surgical success was defined as the absence of bulge symptoms and no re‐treatment for prolapse. Results: Of 641 eligible patients, response rate was 51.0%. 62.7% of subjects had hysterectomy prior to index surgery. Surgical success was noted in 72.9% of younger and 82.2% of older subjects (Adjusted odds ratio [aOR] 1.72, 95% CI [0.93, 3.17]). Older women had greater improvement from baseline in PFDI‐20 score (−87.5 [IQR 74.0] vs −54.2 [IQR 80.2], P = 0.01). Retreatment rate and surgical complication rates were similar between groups (both P > 0.05). Conclusions: Older and younger women had similar surgical success rates a minimum of 3 years post‐operative; however, older women had a greater overall symptom severity improvement. This information may be helpful in counseling older women regarding surgical expectations and decision‐making. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]