Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.

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.

Urinary basement membrane graft-augmented sacrospinous ligament suspension: a description of technique and short-term outcomes.

INTRODUCTION AND HYPOTHESIS: Since the discontinuation of manufacture and distribution of surgical mesh for transvaginal prolapse repair, the use of biologic grafts for transvaginal apical suspension has gained renewed attention. However, there is no FDA-approved device and minimal published data describing such an approach. The objective of this video is to describe a technique and to present limited short-term outcomes utilizing a porcine urinary basement membrane (UBM) graft to perform an augmented bilateral sacrospinous ligament suspension (SSLS). METHODS: We present a step-by-step overview of our technique to perform an augmented SSLS with off-label utilization of a 7- × 10-cm porcine UBM graft. We demonstrate graft shaping and application during transvaginal repair along with data describing perioperative outcomes associated with a series of 25 cases performed at our institution using the technique described. RESULTS: No perioperative complications related to the graft were observed in our cohort. The most common postoperative concern was buttock pain, which spontaneously resolved within 6 months. Two individuals (8%) developed recurrent prolapse within 1 year of surgery. CONCLUSIONS: The UBM-augmented apical suspension allows for reinforced transvaginal prolapse repair without the use of permanent mesh material. We have observed good clinical success in our application of this technique, but dedicated research assessing long-term outcomes compared with a native tissue repair is needed.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four-hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) compared with midurethral sling alone for mixed incontinence with 1-year follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective or objective failure or both. Subjective failure was defined as not meeting the minimal clinical important difference for improvement on the UDI (Urogenital Distress Inventory) total score (26.1 points). Objective failure was defined as not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for persistent urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: One hundred twelve of 379 (29.6%) women had overall treatment failure, with 56 of 379 (14.7%) undergoing additional treatment but only two needing intervention for stress incontinence. Previous overactive bladder (OAB) medication (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.96, 95% CI 1.17-3.31); detrusor overactivity on cystometrogram (OR 2.25, aOR 2.82, 95% CI 1.60-4.97); and higher volume at first urge (OR 1.03, aOR 1.04, 95% CI 1.01-1.07) were associated with overall failure. Worse UDI-urgency scores were associated with failure, with an added interaction effect in the midurethral sling-alone group. CONCLUSIONS: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling in women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. Overall, the need for additional urinary treatment was low and primarily for OAB. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.

BACKGROUND: Prolapse 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. OBJECTIVE: This 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 DESIGN: This 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. RESULTS: Of 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). CONCLUSION: The 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.

Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?

OBJECTIVES: There is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity. METHODS: This is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22. RESULTS: A total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138). CONCLUSIONS: In this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.

Methods for the defining mechanisms of anterior vaginal wall descent (DEMAND) study.

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.

Polycarbonate Urethane Mesh: A New Material for Pelvic Reconstruction.

OBJECTIVE: Polycarbonate urethane (PCU) is a new biomaterial, and its mechanical properties can be tailored to match that of vaginal tissue. We aimed to determine whether vaginal host immune and extracellular matrix responses differ after PCU versus lightweight polypropylene (PP) mesh implantation. METHODS: Hysterectomy and ovariectomy were performed on 24 Sprague-Dawley rats. Animals were divided into 3 groups: (1) PCU vaginal mesh, (2) PP vaginal mesh, and (3) sham controls. Vagina-mesh complexes or vaginas (controls) were excised 90 days after surgery. We quantified responses by comparing: (1) histomorphologic scoring of hematoxylin and eosin- and Masson trichrome-stained slides, (2) macrophage subsets (immunolabeling), (3) pro-inflammatory and anti-inflammatory cytokines (Luminex panel), (4) matrix metalloproteinase (MMP)-2 and -9 using an enzyme-linked immunosorbent assay, and (5) type I/III collagen using picrosirius red staining. RESULTS: There was no difference in histomorphologic score between PCU and PP (P = 0.211). Although the histomorphologic response was low surrounding all mesh fibers, groups with PCU and PP mesh had a higher histomorphologic score than the control group (P < 0.005 and P < 0.002, respectively). There were no differences between groups in terms of macrophage subsets, pro-inflammatory cytokines, anti-inflammatory cytokines, MMP-2 and MMP-9, or collagen ratio. CONCLUSIONS: Polycarbonate urethane, an elastomer with material properties similar to those of vaginal tissue, elicits minimal host inflammatory responses in a rat model. Because its implantation does not elicit more inflammation than currently used lightweight PP, using PCU for prolapse mesh warrants further investigation with larger animal models.

Streamlining Postoperative Void Trials: A Study Comparing Standard Backfill Versus Backfill in the Operating Room.

OBJECTIVE: The standard backfill void trial (VT) performed after urogynecologic surgery is time-consuming. We adopted a new VT protocol in which the bladder is backfilled in the operating room (OR). We hypothesized that this protocol would result in (1) shorter postoperative care unit (PACU) stay and (2) lower rates of postoperative catheterization compared with standard VT. METHODS: We performed a retrospective cohort study of women who underwent same-day urogynecologic surgery between August 2018 and March 2019. Basic demographic and procedure information was collected. Patients were divided into 2 groups based on VT performed. Continuous and categorical variables were compared using Student t tests and χ2 tests, respectively. A linear regression model for PACU length of stay was used to control for confounders. RESULTS: Two hundred twenty-five women were included. One hundred eleven (49.3%) had the OR backfill VT and 114 (50.7%) had the standard VT. There were no statistically significant between-group differences in demographics or procedures performed. The average time in PACU was 15 minutes shorter in the OR backfill compared with the standard VT group (154.8 ± 60.6 vs 169.8 ± 83.2, P = 0.12). After adjusting for confounders, having the OR backfill VT resulted in a 23-minute reduction in PACU time (ß = -23.7; 95% confidence interval, -41.3 to -6.1; P = 0.009). The overall VT failure rate was 21.3% and was not significantly different between groups (24.3% vs 18.4%, P = 0.28). CONCLUSIONS: The OR backfill VT resulted in a shorter stay in PACU without increasing the incidence of postoperative catheterization. With the transition to enhanced recovery after surgery protocols, streamlining PACU activities is a priority.

Evaluation of Host Immune Cellular and Extracellular Matrix Responses to Prolapse Mesh With and Without Tension in a Rat Model.

OBJECTIVES: We sought to determine whether vaginal host immune cellular and extracellular matrix responses are altered in a rat sacrocolpopexy model when lightweight polypropylene mesh is attached on tension versus without tension. METHODS: We performed hysterectomy and ovariectomy in 32 Sprague-Dawley rats. Animals were assigned to 4 groups (n = 8/group): (1) controls with sham operation only (control), (2) mesh sutured only on the vagina (vaginal mesh), (3) sacrocolpopexy without tension, and (4) sacrocolpopexy with tension. Ninety days later, we excised vagina-mesh complexes. A histomorphologic scoring system of hematoxylin/eosin and Masson trichrome stained slides was used to assess host inflammatory responses. The cellular inflammatory response was further quantified using (1) identification of M1 and M2 macrophage subsets and (2) quantification of proinflammatory and anti-inflammatory cytokines. The extracellular matrix response was evaluated by measuring (1) matrix metalloproteinase-2 and matrix metalloproteinase-9 levels and (2) type I/III collagen. RESULTS: Histomorphological tissue responses were greater in all groups with mesh compared with sham controls. Both sacrocolpopexy groups had similar scores, but each group scored significantly higher than the vaginal mesh group. Among the 4 groups, there were no statistically significant differences in M1 or M2 macrophage subsets, proinflammatory or anti-inflammatory cytokines, or extracellular matrix remodeling responses. CONCLUSIONS: Attachment of prolapse mesh resulted in an increased histologic inflammatory response independent of tension. Other markers of cellular inflammation and extracellular matrix remodeling showed no differences among experimental groups. Tension on lightweight polypropylene mesh did not significantly alter the host response in this rat sacrocolpopexy model.

Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.

OBJECTIVE: To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence. METHODS: Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated. RESULTS: Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure. CONCLUSION: Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959347.

Does Mesh Weight Affect Time to Failure After Robotic-Assisted Laparoscopic Sacrocolpopexy?

OBJECTIVE: The objective of this study was to compare time to anatomic failure after robotic sacrocolpopexy with use of ultralightweight versus heavier weight mesh types. METHODS: We performed a retrospective cohort study of women who underwent robotic sacrocolpopexy, from January 2012 to September 2016. We compared (1) sacrocolpopexy with ultralightweight mesh (≤20 g/m) versus (2) sacrocolpopexy with heavier weight mesh (≤35 g/m). Our primary outcome was time to anatomic failure, defined as recurrent prolapse beyond the hymen, or retreatment for prolapse with surgery or pessary. Secondary outcomes were compartment of failure and mesh exposure. Cox proportional hazards modeling was used to estimate the hazard of failure based on mesh type. RESULTS: Of 461 patients, 248 (53.8%) underwent sacrocolpopexy with ultralightweight mesh and 213 (46.2%) with heavier weight mesh. Failures occurred in 37 women, with 21 in the ultralightweight mesh group and 16 in the heavier weight mesh group. Time to failure was statistically significant between groups (P = 0.03). Ultralightweight mesh had twice the hazard of failure within 3 years compared with heavier weight mesh (hazard ratio, 2.15; 95% confidence interval, 1.10-4.21; P = 0.03). Among failures, use of ultralightweight mesh was associated with almost 5 times the hazard of anterior compartment failure (hazard ratio, 4.46; 95% confidence interval, 1.39-14.27; P = 0.01). There was no difference in time to posterior failure. Of 17 mesh exposures, there were fewer in the ultralightweight mesh group, although this group was followed for less time (1.6% ultralightweight vs 6.0% heavier weight, P = 0.01). CONCLUSIONS: Women receiving ultralightweight mesh are more likely to experience earlier anatomic failure in the anterior compartment.

Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.

Importance: Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking. Objective: To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms. Design, Setting, and Participants: Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017. Interventions: Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207). Main Outcomes and Measures: The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms. Results: Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only). Conclusions and Relevance: Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT01959347.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension.

OBJECTIVE: To compare anatomic outcomes after native tissue vaginal vault suspension among women categorized by their preoperative and 6-week postoperative genital hiatus size. METHODS: We performed a retrospective cohort study in women who underwent native tissue vaginal vault suspension between 2005 and 2015. We defined a wide genital hiatus as 4 cm or greater and a normal genital hiatus as less than 4 cm. We compared three groups: 1) women with a wide genital hiatus preoperatively and 6 weeks postoperatively (persistently wide group), 2) women with a wide genital hiatus preoperatively but normal genital hiatus 6 weeks postoperatively (improved group), and 3) women with a normal genital hiatus preoperatively and 6 weeks postoperatively (stably normal group). Our primary outcome was composite anatomic failure at medium term, defined as either recurrent prolapse beyond the hymen or retreatment for prolapse with surgery or a pessary. Data were analyzed with appropriate bivariate analysis and logistic regression. RESULTS: Our study population consisted of 260 women, with 39 of 260 (15.0%) in the persistently wide group, 157 of 260 (60.4%) improved, and 64 of 260 (24.6%) stably normal. Composite anatomic failure was significantly more likely in the persistently wide cohort as compared with the other groups (persistently wide 51.3%, improved 16.6%, stably normal 6.3%, overall P<.01, significant for all pairwise comparisons). These results were consistent when examining the anterior, apical, and posterior compartments individually. In a logistic regression analysis, the persistently wide group was associated with a 4.4-fold increased odds of composite failure (adjusted odds ratio [OR] 4.41, 95% CI 1.99-9.76, P<.01) compared with the improved group and a 15.8-fold increased odds compared with the stably normal group (adjusted OR 15.79, 95% CI 4.66-53.57, P<.01). CONCLUSION: Women with a preoperative genital hiatus 4 cm or greater that is not surgically normalized after native tissue vaginal vault suspension are at significantly increased odds of anatomic failure in all compartments.

Open sacrocolpopexy and vaginal apical repair: retrospective comparison of success and serious complications.

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.

Surgical Outcomes After Apical Repair for Vault Compared With Uterovaginal Prolapse.

OBJECTIVE: To retrospectively compare surgical success and complications between vaginal vault prolapse compared with uterovaginal prolapse in women who underwent apical prolapse repair for stage II-IV prolapse. METHODS: Women in one of three Pelvic Floor Disorders Network prolapse surgical trials were included. Absence of bothersome bulge symptoms, no prolapse beyond the hymen, and no subsequent prolapse treatment defined success and was our primary outcome. Secondary outcomes included comparison of quality-of-life measures, anatomic changes, and adverse events. Pelvic organ prolapse quantification (POP-Q) and quality-of-life measures were administered at baseline and 1-2 years postoperatively. Comparisons were controlled for study site, age, body mass index, baseline POP-Q, apical and anterior or posterior repair performed, and prior prolapse repair. Outcomes measured at multiple time points were analyzed using longitudinal models to assess whether differences existed across study follow-up. RESULTS: Four hundred twenty-one women underwent vault prolapse, and 601 underwent uterovaginal prolapse apical repair. The vault prolapse group was older, more likely to be white, and to have prior urinary incontinence or prolapse repair, stage IV prolapse, and more prolapse bother on a validated scale (all P≤.034). The vault prolapse group was more likely to undergo sacrocolpopexy (228/421 [54%] vs 93/601 [15%]); the uterovaginal prolapse group was more likely to undergo vaginal repair (508/601 [85%] vs 193/421 [46%] P<.001). There were no differences in success (odds ratio [OR] 0.76 for vault prolapse vs uterovaginal prolapse, 95% CI 0.51-1.15, P=.20), changes in Pelvic Organ Prolapse Distress Inventory scores (-79.4 vs -79.8, P=.89), postoperative POP-Q point C measurements (-7.0 vs -7.1 cm, P=.41), or serious adverse events (86/421 [20%] vs 90/601 [15%], P=.86) between groups. Among women who underwent a vaginal approach for repair of vault prolapse (n=193) or uterovaginal prolapse (n=508), there were no differences in success rates (OR 0.67, 95% CI 0.43-1.04, P=.09) at 1-2 years postoperatively. CONCLUSION: Surgical success of stage II-IV vault prolapse and uterovaginal prolapse apical repair was similar whether performed vaginally or abdominally at 1-2 years postoperatively.

Vaginal Uterosacral Ligament Suspension: A Retrospective Cohort of Absorbable and Permanent Suture Groups.

OBJECTIVE: The aim of this study was to compare anatomic results after vaginal uterosacral ligament suspension with absorbable versus permanent suture. METHODS: We performed a retrospective cohort study of women who underwent vaginal uterosacral ligament suspension, from 2006 to 2015. We compared 2 groups: (1) absorbable suspension suture and (2) permanent suspension suture (even if accompanied by absorbable suture). Our primary outcome was composite anatomic failure defined as (1) recurrent prolapse in any compartment past the hymen or (2) retreatment for prolapse. Continuous variables were analyzed using the Student t test or Mann-Whitney U test, and categorical variables were analyzed using χ or Fisher exact test. Multivariable logistic regression analysis was performed to control for confounders. P < 0.05 was considered significant. RESULTS: Of the 242 patients with medium-term follow-up (3 months to 2 years after surgery), 188 underwent vaginal uterosacral ligament suspension with only absorbable suture, and 54 underwent suspension with permanent suture. Compared with the absorbable suture cohort, the permanent suture cohort was more likely to have had advanced preoperative prolapse (P = 0.01), less likely to have had a prior hysterectomy (P = 0.01), and less likely to have undergone a concomitant posterior colporrhaphy/perineoplasty (P < 0.01). Overall, there were no differences in composite anatomic failure between the absorbable and permanent suture groups (17.0% vs 20.4%, P = 0.41). In multivariable logistic regression analyses, when controlling for covariates, there remained no difference in composite anatomic failure between permanent and absorbable suture groups. CONCLUSIONS: Completion of vaginal uterosacral ligament suspension using only absorbable suture affords similar anatomic outcomes in the medium term as compared with suspension with additional permanent suture.

Perioperative Behavioral Therapy and Pelvic Muscle Strengthening Do Not Enhance Quality of Life After Pelvic Surgery: Secondary Report of a Randomized Controlled Trial.

BACKGROUND: There is significant need for trials evaluating the long-term effectiveness of a rigorous program of perioperative behavioral therapy with pelvic floor muscle training (BPMT) in women undergoing transvaginal reconstructive surgery for prolapse. OBJECTIVE: The purpose of this study was to evaluate the effect of perioperative BPMT on health-related quality of life (HRQOL) and sexual function following vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). DESIGN: This study is a secondary report of a 2 × 2 factorial randomized controlled trial. SETTING: This study was a multicenter trial. PARTICIPANTS: Participants were adult women with stage 2-4 POP and SUI. INTERVENTION: Perioperative BPMT versus usual care and sacrospinous ligament fixation (SSLF) versus uterosacral ligament suspension (ULS) were provided. MEASUREMENTS: Participants undergoing transvaginal surgery (SSLF or ULS for POP and a midurethral sling for SUI) received usual care or five perioperative BPMT visits. The primary outcome was change in body image and in Pelvic Floor Impact Questionnaire (PFIQ) short-form subscale, 36-item Short-Form Health Survey (SF-36), Pelvic Organ Prolapse-Urinary Incontinence Sexual Questionnaire short form (PISQ-12), Patient Global Impression of Improvement (PGII), and Brink scores. RESULTS: The 374 participants were randomized to BPMT (n = 186) and usual care (n = 188). Outcomes were available for 137 (74%) of BPMT participants and 146 (78%) of the usual care participants at 24 months. There were no statistically significant differences between groups in PFIQ, SF-36, PGII, PISQ-12, or body image scale measures. LIMITATIONS: The clinicians providing BPMT had variable expertise. Findings might not apply to vaginal prolapse procedures without slings or abdominal apical prolapse procedures. CONCLUSIONS: Perioperative BPMT performed as an adjunct to vaginal surgery for POP and SUI provided no additional improvement in QOL or sexual function compared with usual care.

Do Mixed-Flora Preoperative Urine Cultures Matter?

OBJECTIVES: To determine whether mixed-flora preoperative urine cultures, as compared with no-growth preoperative urine cultures, are associated with a higher prevalence of postoperative urinary tract infections (UTIs). METHODS: This was a retrospective cohort study. Women who underwent urogynecologic surgery were included if their preoperative clean-catch urine culture result was mixed flora or no growth. Women were excluded if they received postoperative antibiotics for reasons other than treatment of a UTI. Women were divided into two cohorts based on preoperative urine culture results-mixed flora or no growth; the prevalence of postoperative UTI was compared between cohorts. Baseline characteristics were compared using χ2 or Student t tests. A logistic regression analysis then was performed. RESULTS: We included 282 women who were predominantly postmenopausal, white, and overweight. There were many concomitant procedures; 46% underwent a midurethral sling procedure and 68% underwent pelvic organ prolapse surgery. Preoperative urine cultures resulted as mixed flora in 192 (68%) and no growth in 90 (32%) patients. Overall, 14% were treated for a UTI postoperatively. There was no difference in the proportion of patients treated for a postoperative UTI between the two cohorts (25 mixed flora vs 13 no growth, P = 0.77). These results remained when controlling for potentially confounding variables in a logistic regression model (adjusted odds ratio 0.92, 95% confidence interval 0.43-1.96). CONCLUSIONS: In women with mixed-flora compared with no-growth preoperative urine cultures, there were no differences in the prevalence of postoperative UTI. The clinical practice of interpreting mixed-flora cultures as negative is appropriate.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

INTRODUCTION AND HYPOTHESIS: Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. METHODS: ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. RESULTS: The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. CONCLUSIONS: We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.