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.

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.

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.

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.

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.

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.

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.

Vaginal native tissue repair versus transvaginal mesh repair for apical prolapse: how utilizing different methods of analysis affects the estimated trade-off between reoperation for mesh exposure/erosion and reoperation for recurrent prolapse.

INTRODUCTION AND HYPOTHESIS: Informed decision-making about optimal surgical repair of apical prolapse with vaginal native tissue (NT) versus transvaginal mesh (TVM) requires understanding the balance between the potential "harm" of mesh-related complications and the potential "benefit" of reducing prolapse recurrence. Synthesis of data from observational studies is required and the current literature shows that the average follow-up for NT repair is significantly longer than for TVM repair. We examined this harm/benefit balance. We hypothesized that using different methods of analysis to incorporate follow-up time would affect the balance of outcomes. METHODS: We used a Markov state transition model to estimate the cumulative 24-month probabilities of reoperation for mesh exposure/erosion or for recurrent prolapse after either NT or TVM repair. We used four different analytic approaches to estimate probability distributions ranging from simple pooled proportions to a random effects meta-analysis using study-specific events per patient-time. RESULTS: As variability in follow-up time was accounted for better, the balance of outcomes became more uncertain. For TVM repair, the incremental ratio of number of operations for mesh exposure/erosion per single reoperation for recurrent prolapse prevented increased progressively from 1.4 to over 100 with more rigorous analysis methods. The most rigorous analysis showed a 70% probability that TVM would result in more operations for recurrent prolapse repair than NT. CONCLUSIONS: Based on the best available evidence, there is considerable uncertainty about the harm/benefit trade-off between NT and TVM for apical prolapse repair. Future studies should incorporate time-to-event analyses, with greater standardization of reporting, in order to better inform decision-making.

Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery.

OBJECTIVE: This planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception. STUDY DESIGN: Sham suprapubic tension-free vaginal tape (TVT) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT. Primary surgical outcomes and maintenance of blinding was assessed at 12 months. Knowledge of treatment assignment was compared between groups, and the relationship with treatment success rates was assessed. RESULTS: Prior to the 12 month postoperative visit, only 4% of treated participants (13 of 336) formally reported unmasking. At 12 months, 94% of the randomized participants (315 of 336) provided treatment knowledge data. Sixteen TVT participants (10%) reported treatment knowledge; most (n = 15, 94%) were correct; 17 of the sham participants (11%) reported treatment knowledge; half (n = 8, 47%) were correct. Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment (sham, 46 [33%] vs TVT, 44 [33%]). We did not detect significant differences in treatment success rates based on perception within and across received treatment groups (perceived sham vs TVT overall [P = .76]). Of those receiving TVT, more participants perceiving TVT had treatment success compared with those who perceived sham (84% vs 74%; P = .29). Among sham participants, more participants perceiving sham had success compared with those who perceived receiving TVT (65% vs 56%; P = .42). CONCLUSION: Sham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.

Does concomitant anterior/apical repair during midurethral sling improve the overactive bladder component of mixed incontinence?

INTRODUCTION AND HYPOTHESIS: Midurethral sling (MUS) can improve overactive bladder (OAB) symptoms. It is unclear if anterior/apical prolapse (AA) repair provides additional benefit. We hypothesized that women with mixed urinary incontinence (MUI) experience greater improvement in the OAB component of their symptoms after concomitant MUS and AA repair compared with MUS alone. METHODS: This is a retrospective cohort study of women with bothersome MUI (defined by objective stress test and validated questionnaire) undergoing MUS alone ("MUS-only") or concomitant MUS and AA repair ("MUS + AA"). Our primary outcome was the Overactive Bladder Questionnaire Symptom Severity (OAB-q SS) change score 6 weeks after surgery. RESULTS: Of 151 women, 67 (44 %) underwent MUS-only and 84 (56 %) underwent MUS + AA. The MUS-only cohort was younger and had less severe baseline prolapse (p < 0.05 for both). Postoperative complications (predominantly UTI) occurred in 35 (23 %) patients and were similar between cohorts. For all subjects mean OAB-q SS scores significantly improved postoperatively (p < 0.05). Our primary outcome, OAB-q SS change score, showed no significant differences between cohorts (30 ± 26 MUS-only vs 25 ± 25 MUS + AA, p = 0.20), indicating similar improvements in OAB symptoms. Multivariate linear regression analysis revealed no difference in OAB-q SS change score between cohorts; however, OAB-q SS change scores were lower for women with a postoperative complication (ß = -19, 95 % CI -31 to -6; p < 0.01). CONCLUSIONS: In women with bothersome MUI, concomitant AA repair does not result in additional improvement in OAB symptoms over MUS alone. Patients with postoperative complications exhibit less improvement in OAB symptoms.

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial.

IMPORTANCE: More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE: To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS: The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES: The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS: At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE: Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00597935.

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.

Trends in use of surgical mesh for pelvic organ prolapse.

OBJECTIVE: Limited data exist on the rates of pelvic organ prolapse procedures utilizing mesh. The objective of this study was to examine trends in vaginal mesh prolapse procedures (VMs), abdominal sacrocolpopexy (ASC), and minimally invasive sacrocolpopexy (MISC) from 2005 to 2010. STUDY DESIGN: We utilized deidentified, adjudicated health care claims data from across the United States from 2005 to 2010. Among women 18 years old or older, we identified all mesh prolapse procedures based on current procedural terminology codes (57267 for VM, 57280 for ASC, and 57425 for MISC). VM procedures included all vaginal prolapse surgeries in which mesh was placed, whether in the anterior, apical, or posterior compartment. We estimated rates per 100,000 person-years (100,000 py) and 95% confidence intervals (CIs). RESULTS: During 78.5 million person-years of observation, we identified 60,152 mesh prolapse procedures, for a rate of 76.0 per 100,000 py (95% CI, 73.6-78.5). Overall, VMs comprised 74.9% of these surgeries for an overall rate of 56.9 per 100,000 py (95% CI, 55.0-58.9). Rates of ASC and MISC were considerably lower at 12.0 per 100,000 py (95% CI, 11.6-12.5) and 9.5 per 100,000 py (95% CI, 9.2-9.9), respectively. Among sacrocolpopexies, ASC was more common than MISC in 2005-2007; however, since 2007, the rate of MISC has increased, whereas the rate of ASC has decreased. Regarding trends by age, VM was considerably more common than sacrocolpopexies at all ages, and ASC was more common than MISC in women older than 50 years. CONCLUSION: From 2005 to 2010, the rate of mesh prolapse procedures has increased, with vaginal mesh surgeries constituting the vast majority.

Computer modeling informs study design: vaginal estrogen to prevent mesh erosion after different routes of prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Many clinicians use perioperative vaginal estrogen therapy (estradiol, E(2)) to diminish the risk of mesh erosion after prolapse surgery, though supporting evidence is limited. We assessed the feasibility of a factorial randomized trial comparing mesh erosion rates after vaginal mesh prolapse surgery (VM) versus minimally invasive sacral colpopexy (MISC), with or without adjunct vaginal estrogen therapy. METHODS: A Markov state transition model simulated the probability of 2-year outcomes of visceral injury, mesh erosion, and reoperation after four possible prolapse therapies: VM or MISC, each with or without estrogen therapy (E(2)). We used pooled estimates from a systematic review to generate probability distributions for the following outcomes after each procedure: visceral injury, postoperative mesh erosion, and reoperation for either recurrent prolapse or mesh erosion. Assuming different assumptions for E(2) efficacies (50 and 75 % reduction in erosion rates), Monte Carlo simulations estimated outcomes rates, which were then used to generate sample size estimates for a four-arm factorial trial. RESULTS: While E(2) reduced the risk of mesh erosion for both VM and MISC, absolute reduction was small. Assuming 75 % efficacy, E(2) decreased the risk of mesh erosion for VM from 7.8 to 2.0 % and for MISC from 2.0 to 0.5 %. Total sample sizes ranged from 448 to 1,620, depending on power and E(2) efficacy. CONCLUSIONS: The required sample size for a trial to determine which therapy results in the lowest erosion rates would be prohibitively large. Because this remains an important clinical issue, further study design strategies could include composite outcomes, cost-effectiveness, or value of information analysis.

Long-term outcomes of vaginal mesh versus native tissue repair for anterior vaginal wall prolapse.

INTRODUCTION AND HYPOTHESIS: To estimate the risk of repeat surgery for recurrent prolapse or mesh removal after vaginal mesh versus native tissue repair for anterior vaginal wall prolapse. METHODS: We utilized longitudinal, adjudicated, healthcare claims from 2005 to 2010 to identify women ≥18 years who underwent an anterior colporrhaphy (CPT 57420) with or without concurrent vaginal mesh (CPT 57267). The primary outcome was repeat surgery for anterior or apical prolapse or for mesh removal/revision; these outcomes were also analyzed separately. We utilized Kaplan-Meier curves to estimate the cumulative risk of each outcome after vaginal mesh versus native tissue repair. Cox proportional hazards models were used to estimate the hazard ratio (HR) for vaginal mesh versus native tissue repair, adjusted for age, concurrent hysterectomy, and concurrent or recent sling. RESULTS: We identified 27,809 anterior prolapse surgeries with 49,658 person-years of follow-up. Of those, 6,871 (24.7%) included vaginal mesh. The 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue (15.2 % vs 9.8 %, p <0.0001) with a 5-year risk of mesh revision/removal of 5.9%. The 5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4 % vs 9.3 %, p = 0.70. The results of the adjusted Cox model were similar (HR 0.93, 95%CI: 0.83, 1.05). CONCLUSIONS: The use of mesh for anterior prolapse was associated with an increased risk of any repeat surgery, which was driven by surgery for mesh removal. Native tissue and vaginal mesh surgery had similar 5-year risks for surgery for recurrent prolapse.

Obesity as a risk for the recurrence of anterior vaginal wall prolapse after anterior colporrhaphy.

OBJECTIVE: To determine whether obese body mass index is associated with the recurrence of anterior vaginal wall prolapse after anterior colporrhaphy. STUDY DESIGN: We conducted a retrospective cohort study of the risk of recurrent anterior prolapse 6 months after anterior colporrhaphy in normal weight/overweight versus obese women from January 2004 to December 2010. Women who underwent a concurrent apical prolapse procedure were excluded. Data were abstracted regarding sociodemographics, physical examination, operative reports, and postoperative follow-up visits. RESULTS: Of 282 subjects 192 (68%) were normal/overweight and 90 (32%) were obese. Median time of follow-up was 1.8 months (interquartile range [IQR] 1.4-6.2) in the normal/overweight group and 2.0 months (IQR 1.4-5.9) in the obese group. The overall risk of recurrent prolapse was 15.2%. In bivariate analysis there was a trend towards higher recurrence in the obese versus the normal/overweight cohort (21.1% vs. 12.5%, p = 0.06). In the logistic regression model, which adjusted for age, race, diabetes, constipation, cigarette use, concurrent sling, and prior hysterectomy, obesity became significantly associated with recurrent anterior prolapse (odds ratio 2.5, 95% confidence interval 1.2-5.3). CONCLUSION: The risk of recurrence after anterior colporrhaphy is relatively high in the short-term. Obesity is associated with increased odds of anatomic recurrence of anterior vaginal wall prolapse.

The efficacy of posterior tibial nerve stimulation for the treatment of overactive bladder in women: a systematic review.

INTRODUCTION AND HYPOTHESIS: Posterior tibial nerve stimulation (PTNS) is a percutaneous method of peripheral, sacral neuromodulation. Its current use is limited; however, published data suggest PTNS may be an effective treatment for overactive bladder (OAB). METHODS: We systematically reviewed the literature on PTNS for treatment of idiopathic OAB in women from January 2000 to August 2010 published in English in MEDLINE/PubMed, Embase, and Cochrane databases. We included randomized controlled trials or observational studies reporting objective outcome measures with the use of either the Urgent PC or Stoller Afferent Nerve Stimulator (SANS) for PTNS. Studies were considered "good quality" if results from objective measures were provided for ≥20 women, results distinguished between type of OAB symptom, and data were reported separately for female subjects. RESULTS: Of the 136 identified articles, 17 met inclusion criteria for data abstraction; 4 of the 17 studies met our criteria for good quality and reported success rates of 54-93 %. Recurrent limitations in the literature were pooling of results for male and female subjects and lack of differentiation in the data on specific symptoms of OAB treated. Short-term follow-up and infrequent use of a control arm were also noted shortcomings of reviewed studies. CONCLUSIONS: Limited high quality data exist on PTNS for OAB in women. Although initial studies have demonstrated promise, more comprehensive evaluation of PTNS is needed to support its universal use for the treatment of OAB in women.

Do urodynamic parameters predict persistent postoperative stress incontinence after midurethral sling? A systematic review.

INTRODUCTION AND HYPOTHESIS: It is unclear whether preoperative urodynamic study (UDS) values are predictive of outcomes after midurethral sling. MATERIALS AND METHODS: We systematically reviewed multiple databases from January 1989 to October 2011 for English-language studies correlating UDS data with postoperative outcomes after midurethral slings. We performed random effects model meta-analyses, as indicated. Relative risk (RR) ratios for the outcome of stress urinary incontinence (SUI) cure were calculated using high maximum urethral closure pressure (MUCP) and Valsalva leak point pressure (VLPP) values as the reference group. RESULTS: High preoperative MUCP was associated with cure after retropubic [RR 0.67; 95% confidence interval (CI) 0.47-0.97)] and transobturator slings (RR 0.65; 95% CI 0.49-0.90). High preoperative VLPP was also associated with cure after retropubic sling (RR 0.89; 95% CI 0.82-0.96), but this relationship did not achieve statistical significance for cure after transobturator sling (RR 0.86; 95% CI 0.74-1.00). CONCLUSIONS: Preoperative MUCP and VLPP values may add insight into postoperative outcomes after surgical treatment for SUI.

Trends in inpatient urinary incontinence surgery in the USA, 1998-2007.

INTRODUCTION AND HYPOTHESIS: This study was conducted to assess national rates in stress urinary incontinence (SUI) surgery in the USA from 1998 to 2007. METHODS: We utilized the 1998-2007 Nationwide Inpatient Sample and assessed women aged 20 years and older who underwent SUI surgery based on the International Classification of Diseases, 9th Revision (ICD-9) procedure and diagnosis codes. RESULTS: The total number of SUI surgeries performed during this 10-year period was 759,821. The annual number of procedures increased from 37,953 in 1998 to 94,910 in 2007. The type of SUI surgery performed also changed (p < 0.001). In 1998, retropubic suspensions represented 52.3%, decreasing to 13.8% in 2007. "Other repair of SUI" (ICD-9 59.79) comprised 22.4% in 1998, increasing to 75.2% in 2007, likely representing midurethral slings. CONCLUSIONS: The total number and incidence rates of SUI surgeries have increased from 1998 to 2007. The type of SUI surgery performed has also changed significantly, likely secondary to adoption of midurethral slings.