A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair.

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. STUDY DESIGN: A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was 280. RESULTS: Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval, -0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. CONCLUSION: For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

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

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

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

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

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.

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

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

Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial.

Importance: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. Objective: To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. Design, Setting, Participants: At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. Interventions: Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. Main Outcomes and Measures: The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. Results: A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). Conclusions and Relevance: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension. Trial Registration: ClinicalTrials.gov Identifier: NCT01802281.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study.

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

Decreasing transobturator sling groin pain without decreasing efficacy using TVT-Abbrevo.

INTRODUCTION AND HYPOTHESIS: Groin pain following a transobturator (TO) midurethral sling is not uncommon and can be difficult to manage. We sought to determine if decreasing the mesh burden in the groin would decrease pain. The primary objective was to compare the incidence of post-operative groin pain following placement of full-length TVT-Obturator versus the shorter TVT-Abbrevo. Secondarily, we aimed to compare the efficacy between both devices 6 months after surgery. METHODS: This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 October 2013. Charts were reviewed and the incidence of post-operative groin pain in the two groups dichotomized as present or absent and compared using a Chi-squared test. Validated questionnaire scores of the groups were compared using t tests. RESULTS: There were 125 patients who received a TVT-Obturator and 100 patients who received a TVT-Abbrevo. No differences in demographic data were present between the groups. Twelve patients (9.6 %) in the TVT-Obturator group and 1 patient (1 %) in the TVT-Abbrevo group experienced bothersome groin pain (P value = 0.007). The complete pre- and 6-month post-operative ISI, UDI-6 and PFIQ-7 scores were available for 76 (61 %), 47 (38 %), and 45 (36 %) patients following TVT-Obturator and 57 (57 %), 30 (30 %), and 28 (28 %) following TVT-Abbrevo treatment. At 6 months the mean improvement in questionnaire scores for the TVT-Obturator and TVT-Abbrevo groups were as follows: 5.0 and 5.1 for ISI (P value = 0.9), 8.3 and 7.9 for UDI-6 (P value = 0.8), and 4.8 and 6.1 for PFIQ-7 (P value = 0.4). CONCLUSION: Use of TVT-Abbrevo reduces post-operative groin pain compared with the full-length TVT-Obturator, without any reduction in efficacy.

The debate over robotics in benign gynecology.

The debate over the role of the da Vinci surgical robotic platform in benign gynecology is raging with increasing fervor and, as product liability issues arise, greater financial stakes. Although the best currently available science suggests that, in the hands of experts, robotics offers little in surgical advantage over laparoscopy, at increased expense, the observed decrease in laparotomy for hysterectomy is almost certainly, at least in part, attributable to the availability of the robot. In this author's opinion, the issue is not whether the robot has any role but rather to define the role in an institutional environment that also supports the safe use of vaginal and laparoscopic approaches in an integrated minimally invasive surgery program. Programs engaging robotic surgery should have a clear and self-determined regulatory process and should resist pressures in place that may preferentially support robotics over other forms of minimally invasive surgery.

Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study.

OBJECTIVE: The purpose of this study was to describe the evaluation and management of synthetic mesh-related complications after surgery for stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). STUDY DESIGN: We conducted a multicenter, retrospective analysis of women who attended 4 US tertiary referral centers for evaluation of mesh-related complications after surgery for SUI and/or POP from January 2006 to December 2010. Demographic, clinical, and surgical data were abstracted from the medical record, and complications were classified according to the Expanded Accordion Severity Classification. RESULTS: Three hundred forty-seven patients sought management of synthetic mesh-related complications over the study period. Index surgeries were performed for the following indications: SUI (sling only), 49.9%; POP (transvaginal mesh [TVM] or sacrocolpopexy only), 25.6%; and SUI + POP (sling + TVM or sacrocolpopexy), 24.2%. Median time to evaluation was 5.8 months (range, 0-65.2). Thirty percent of the patients had dyspareunia; 42.7% of the patients had mesh erosion; and 34.6% of the patients had pelvic pain. Seventy-seven percent of the patients had a grade 3 or 4 (severe) complication. Patients with TVM or sacrocolpopexy were more likely to have mesh erosion and vaginal symptoms compared with sling only. The median number of treatments for mesh complications was 2 (range, 1-9); 60% of the women required ≥2 interventions. Initial treatment intervention was surgical for 49% of subjects. Of those treatments that initially were managed nonsurgically, 59.3% went on to surgical intervention. CONCLUSION: Most of the women who seek management of synthetic mesh complication after POP or SUI surgery have severe complications that require surgical intervention; a significant proportion require >1 surgical procedure. The pattern of complaints differs by index procedure.

Recommendations of the SUFU/AUGS/ICS Female Stress Urinary Incontinence Surgical Publication Working Group: A Common Standard Minimum Data Set for the Literature.

INTRODUCTION AND OBJECTIVES: Relevant, meaningful, and achievable data points are critical in objectively assessing quality, utility, and outcomes in female stress urinary incontinence (SUI) surgery. A minimum data set female SUI surgery studies was proposed by the first American Urological Association guidelines on the surgical management of female SUI in 1997, but recommendation adherence has been suboptimal. The Female Stress Urinary Incontinence Surgical Publication Working Group (WG) was created from members of several prominent organizations to formulate a recommended standard of study structure, description, and minimum outcome data set to be utilized in designing and publishing future SUI studies. The goal of this WG was to create a body of evidence better able to assess the outcomes of female SUI surgery. METHODS: The WG reviewed the minimum data set proposed in the 1997 AUA SUI Guideline document, and other relevant literature. The body of literature was examined in the context of the profound changes in the field over the past 25 years. Through a DELPHI process, a standard study structure and minimum data set were generated. Care was taken to balance the value of several meaningful and relevant data points against the burden of creating an excessively difficult or restrictive standard that would disincentivize widespread adoption and negatively impact manuscript production and acceptance. RESULTS: The WG outlined standardization in four major areas: 1) study design, 2) pretreatment demographics and characterization of the study population, 3) intraoperative events, and 4) post-treatment evaluation, and complications. Forty-two items were evaluated and graded as: STANDARD - must be included; ADDITIONAL - may be included for a specific study and is inclusive of the Standard items; OPTIMAL - may be included for a comprehensive study and is inclusive of the Standard and Additional items; UNNECESSARY/LEGACY - not relevant. CONCLUSIONS: A reasonable, achievable, and clinically meaningful minimum data set has been constructed. A structured framework will allow future surgical interventions for female SUI to be objectively scrutinized and compared in a clinically significant manner. Ultimately, such a data set, if adopted by the academic community, will enhance the quality of the scientific literature, and ultimately improve short and long-term outcomes for female patients undergoing surgery to correct SUI.

Changes in bowel symptoms 1 year after rectocele repair.

OBJECTIVE: We sought to evaluate changes in bowel symptoms after rectocele repair and identify risk factors for persistent symptoms. STUDY DESIGN: We conducted ancillary analysis of a randomized surgical trial for rectocele repair. Subjects underwent examinations and completed questionnaires for bowel symptoms at baseline and 12 months postoperatively. Outcomes included resolution, persistence, or de novo bowel symptoms. We used multiple logistic regression to identify risk factors for bowel symptom persistence. RESULTS: A total of 160 women enrolled: 139 had baseline bowel symptoms and 85% had 12-month data. The prevalence of bowel symptoms decreased after rectocele repair (56% vs 23% splinting, 74% vs 37% straining, 85% vs 19% incomplete evacuation, 66% vs 14% obstructive defecation; P < .001 for all). On multiple logistic regression, a longer history of splinting was a risk factor for persistent postoperative splinting (adjusted odds ratio, 2.25; 95% confidence interval, 1.02-4.93). CONCLUSION: Bowel symptoms may improve after rectocele repair, but almost half of women will have persistent symptoms.

"I'm Not Going Home With a Catheter": Patient-Perceived Outcomes Associated With Perioperative Intermittent Catheterization.

IMPORTANCE: Indwelling catheters are a known source of dissatisfaction for postoperative patients. There is a paucity of data describing patient-perceived outcomes associated with the alternative of intermittent self-catheterization (ISC). OBJECTIVES: The aim of this study was to describe patient satisfaction and outcomes associated with ISC after outpatient female pelvic reconstructive surgery. STUDY DESIGN: This was a secondary analysis of a prospective cohort study at an academic tertiary referral center from September 2018 to June 2021. Participants completed preoperative ISC instruction that included an instructional video, 1:1 demonstration with a health care provider, and provision of ISC supplies. Participants were instructed to perform ISC postoperatively until they had 2 consecutive outpatient PVRs less than one-half the voided volume. Participant satisfaction was assessed 2 weeks postprocedure, with adverse events evaluated at 6 weeks. RESULTS: One hundred sixty participants completed preoperative ISC instruction and were included in this analysis. Mean age was 52.1 (SD +/- 11.4) years, mean body mass index was 28.9 (SD +/- 5.8), and mean time from ISC instruction to surgery was 16.4 (SD +/- 15.7) days. Most participants reported no difficulty with ISC (124/160 [78%]) and had high levels of satisfaction (148/151 [98%]). Difficulty performing ISC was not associated with time since ISC instruction ( P = 0.32), difficulty noted at ISC instruction by the health care provider ( P = 0.24), or the duration of ISC instruction ( P = 0.16). On multiple logistic regression, age, body mass index, and prolapse beyond the hymen did not predict difficulty learning or performing ISC. At 6 weeks postprocedure, 22 of 155 participants (14%) endorsed symptoms of a urinary tract infection, and 15 of 160 (9%) had a culture-proven urinary tract infection. CONCLUSIONS: Women undergoing outpatient pelvic reconstructive surgery report ease and satisfaction with ISC.

Long-Term Outcomes After Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse: A Parallel Cohort Study (eVAULT).

IMPORTANCE: Data on long-term mesh hysteropexy outcomes are limited. This study provides 7-year data from the original VAULT (Vaginal and Laparoscopic Mesh Hysteropexy for Uterovaginal Prolapse Trial) study. OBJECTIVE: The aim of this study was to compare long-term outcomes and success for laparoscopic sacral hysteropexy (LSHP) and vaginal mesh hysteropexy (VMHP). STUDY DESIGN: This multicenter, prospective parallel cohort was an extension to the initial VAULT study. Subjects were contacted, and informed consent was obtained. We collected baseline demographics and the latest Pelvic Organ Prolapse-Quantification examination data from chart review and conducted telephone interviews to update demographic information and collect Pelvic Floor Distress Inventory Short-Form, Patient Global Impression of Improvement, prolapse reoperation/pessary use, and complications. Surgical success was defined as no bulge symptoms, satisfaction score of "very much better" or "much better," and no reoperation/pessary use. RESULTS: Five of 8 original sites enrolled 53 subjects (LSHP n = 34 and VMHP n = 19). The LSHP group was younger (67 vs 74, P < 0.01), but there were no differences in parity, body mass index, menopause, race, insurance, tobacco use, or Charlson Comorbidity Index. The median subjective follow-up was 7.3 ± 0.9 years. Composite success was 82% LSHP versus 74% VMHP. Pelvic Floor Distress Inventory Short-Form composite scores were similar at baseline and improved for both groups (P < 0.01) with lower bother observed in the LSHP group (20.8 vs 43.8, P = 0.01). There were no differences in complications. CONCLUSIONS: Over 7 years after surgery, LSHP and VMHP have high success, low retreatment, and low complication rates that did not differ between groups. Although there is a trend toward better anatomic support in the LSHP group, these findings were not significant and we are underpowered to detect a difference.

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.

Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

Long-term Device Outcomes of Mesh Implants in Pelvic Organ Prolapse Repairs.

OBJECTIVE: To evaluate the longer-term safety and reintervention outcomes of mesh implants in pelvic organ prolapse (POP) repairs. METHODS: We conducted a population-based cohort study of women undergoing POP repairs in inpatient and outpatient surgical settings between 2008 and 2016 in New York State. Multivariable logistic regression was used based on patient and procedural characteristics and hospital volume between mesh and nonmesh groups to obtain propensity scores for each individual. Long-term safety events and reinterventions were assessed using time-to-event analysis. RESULTS: We identified 54,194 women undergoing POP repairs (12,989 with mesh, and 41,205 without mesh). Mean age was 59.8 (±13.1) years, and median follow-up was 4.7 years (interquartile range, 2.4-6.8 years). In the propensity score-matched 12,284 pairs of women, POP repair with mesh was associated with a higher risk of reintervention when compared with POP repair without transvaginal mesh (hazard ratio 1.40, 95% CI 1.27-1.54, P<.001). The estimated risk of undergoing a reintervention at 5 years was 8.8% (95% CI 8.2-9.3%) in the mesh group and 6.3% (5.9-6.8%) in the nonmesh group. Among patients who had reinterventions, 18.5% of those operated with mesh had a reintervention related to mesh-related complications. CONCLUSION: Even though transvaginal mesh has been removed from the market, the risk of mesh complications did not diminish over time and these women warrant close follow-up. Continued surveillance of mesh in POP repairs is essential to ensure safety for the women who have already been implanted.

Immediate Postoperative Pelvic Organ Prolapse Quantification Measures and 2-Year Risk of Prolapse Recurrence.

OBJECTIVE: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction. METHODS: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored. RESULTS: This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9-2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1-2.3) and surgical failure (aOR 1.5; 95% CI 1.0-2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50-0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function. CONCLUSION: A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.