OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS: From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24–2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.

BACKGROUND: Decline in hysterectomies and provider comfort have led to decreased exposure to total vaginal hysterectomy (TVH) during residency training. Commercial simulation products exist but are cost-prohibitive for consistent use in training. METHODS: Pilot study of a novel low fidelity TVH trainer. A complete vaginal hysterectomy trainer was modified from previously published models to include vulva (for operating in confined space) and more realistic-feeling materials. Items used included: “pelvic base”- flower pot and board; “vulva”- pink foam cowboy hat; uterine insert (suspended within pelvic base) composed of “uterus”- pool noodle, “uterosacral ligaments”- elastic bands, “round ligament and fallopian tubes”-long balloons, “ovaries”- round balloons, “vessels and ureters”-pipe cleaners, and “peritoneum”- Press'n Seal. Residents rated confidence in performing TVH, pre- and postsimulation with trainer. RESULTS: Five reusable pelvic bases ($10/base) and 16 replaceable uterine inserts ($2/insert) were constructed. The trainer functioned well with surgical instruments and suture, although reloading the pelvic base was time consuming. All participating residents (n=14) successfully performed the steps of TVH. Change in mean resident confidence was statistically significant pre- (M=2.08/5) and post- (M=3.17/5) simulation, P=.004. DISCUSSION: Our trainer is easily constructed for minimal cost. It can be used in residency training programs to simulate total vaginal hysterectomy and improve resident confidence in performing TVH. We have since updated the base to a flip-top trashcan to facilitate reloading.

ImportanceThere are limited long-term data on patient-reported pain after surgical treatment of uterovaginal prolapse.ObjectiveThis study aimed to evaluate pain in women undergoing minimally invasive total hysterectomy and sacrocolpopexy with a lightweight polypropylene Y-mesh (Upsylon) >2 years after surgery.Study DesignThis is a planned secondary analysis of a 5-site randomized trial comparing permanent versus absorbable suture for vaginal attachment of a lightweight polypropylene Y-mesh during total laparoscopic hysterectomy and sacrocolpopexy in women with stage ≥2 uterovaginal prolapse. Our primary outcome was patient-reported pain or dyspareunia at >2 years.ResultsOf the 185 participants eligible for enrollment in the e-PACT study, 106 enrolled; 98 participants (96%) completed either in-person examinations or study questionnaires regarding pain and are included in this analysis. At >2 years, 28% reported any pain: 14% reported dyspareunia on questionnaires, 5% reported pelvic pain on questionnaires, and 14% of those who had an in-person examination reported pain. Of participants who reported pain or dyspareunia at baseline before surgery, 59% reported resolution of their symptoms >2 years. On multiple logistic regression controlling for age and baseline pain or dyspareunia, baseline pain or dyspareunia was associated with a nearly 3-fold increased risk of reporting any pain >2 years (adjusted odds ratio, 2.7; 95% confidence interval, 1.1–6.9). No women had repeat surgical intervention for pain.ConclusionsAlthough 60% of women report pain resolution >2 years after surgery, de novo pain was present in 1 of 5 women. Baseline history of pain or dyspareunia is the only factor associated with an increased likelihood of experiencing pain >2 years after surgery.

Introduction and hypothesis The objective was to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. Secondary aims were to evaluate surgical success and late adverse events. Methods This extension study included women previously enrolled in the multicenter randomized trial of permanent vs delayed-absorbable suture with lightweight mesh for > stage II uterovaginal prolapse. Owing to COVID-19, women were given the option of an in-person (questionnaires and examination) or telephone visit (questionnaires only). The primary outcome was total and incident suture or mesh exposure, or symptoms suggestive of mesh exposure in women without an examination. Secondary outcomes were surgical success, which was defined as no subjective bulge, no prolapse beyond the hymen, and no pelvic organ prolapse retreatment, and adverse events. Results A total of 182 out of 200 previously randomized participants were eligible for inclusion, of whom 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. At a mean of 3.9 years post-surgery, the rate of mesh or suture exposure was 7.7% (14 out of 182) of whom only 2 were incident cases reported after 1-year follow-up. None reported vaginal bleeding or discharge, dyspareunia, or penile dyspareunia. Surgical success was 93 out of 106 (87.7%): 13 out of 94 (13.8%) failed by bulge symptoms, 2 out of 78 (2.6%) by prolapse beyond the hymen, 1 out of 85 (1.2%) by retreatment with pessary, and 0 by retreatment with surgery. There were no serious adverse events. Conclusions The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, success rates remained high, and there were no delayed serious adverse events.

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