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The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial).

ABSTRACT: We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal prolapse.The selection of the primary outcome measure, timing of randomization, patient and evaluator masking to surgical intervention, collection and adjudication of adverse events, cost effectiveness evaluations, partnering with industry, and surgeon certification of competency to perform the 2 procedures is described. A composite primary outcome of success defined as no prolapse symptoms, no objective prolapse beyond the hymen, and no retreatment of prolapse, with a minimum of 36 months postsurgery follow-up using survival analyses is planned. Secondary outcomes measured at baseline and every 6 months postsurgery include validated condition-specific and general quality of life assessments, global impression of improvement, body image, and sexual function measures. Unique challenges during the trial design include maintenance of patient masking to the intervention with routine gynecologic health maintenance and maintenance of evaluator masking.Recruitment and randomization of 180 participants is complete, and participants are currently in the follow-up phase.This trial will provide information to help surgeons counsel patients and contribute evidence-based information regarding risks and benefits of 2 approaches for the treatment of uterovaginal prolapse.

SUBMITTER: Nager CW

PROVIDER: S-EPMC4919185 | biostudies-literature | 2016 Jul-Aug

REPOSITORIES: biostudies-literature

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The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial).

Nager Charles W CW Zyczynski Halina H Rogers Rebecca G RG Barber Matthew D MD Richter Holly E HE Visco Anthony G AG Rardin Charles R CR Harvie Heidi H Wallace Dennis D Meikle Susan F SF

Female pelvic medicine & reconstructive surgery 20160701 4

<h4>Objectives</h4>We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal pro ...[more]

PMID: 27054798

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Project description:ImportanceVaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.ObjectiveTo compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.Design, setting, participantsAt 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.InterventionsNinety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.Main outcomes and measuresThe 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.ResultsA 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 relevanceAmong 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 registrationClinicalTrials.gov Identifier: NCT01802281.

Project description:BackgroundVaginal 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.ObjectiveOur objective was to compare the efficacy and adverse events of these 2 procedures.Study designAt 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.ResultsA 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.ConclusionAmong 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.

Project description:The treatment of post-hysterectomy vaginal vault prolapse (VVP) has been investigated in several randomized clinical trials (RCTs), but a systematic review of the topic is still lacking. The aim of this study is to compare the effectiveness of treatments for VVP.We performed a systematic review and meta-analysis of the literature on the treatment of VVP found in PubMed and Embase. Reference lists of identified relevant articles were checked for additional articles. A network plot was constructed to illustrate the geometry of the network of the treatments included. Only RCTs reporting on the treatment of VVP were eligible, conditional on a minimum of 30 participants with VVP and a follow-up of at least 6 months.Nine RCTs reporting 846 women (ranging from 95 to 168 women) met the inclusion criteria. All surgical techniques were associated with good subjective results, and without differences between the compared technique, with the exception of the comparison of vaginal mesh (VM) vs laparoscopic sacrocolpopexy (LSC). LSC is associated with a higher satisfaction rate. The anatomical results of the sacrocolpopexy (laparoscopic, robotic [RSC]. and abdominal [ASC]) are the best (62-91%), followed by the VM. However, the ranges of the anatomical outcome of VM were wide (43-97%). The poorest results are described for the sacrospinal fixation (SSF; 35-81%), which also correlates with the higher reoperation rate for pelvic organ prolapse (POP; 5-9%). The highest percentage of complications were reported after ASC (2-19%), VM (6-29%), and RSC (54%). Mesh exposure was seen most often after VM (8-21%). The rate of reoperations carried out because of complications, recurrence prolapse, and incontinence of VM was 13-22%. Overall, sacrocolpopexy reported the best results at follow-up, with an outlier of one trial reporting the highest reoperation rate for POP (11%). The results of the RSC are too small to make any conclusion, but LSC seems to be preferable to ASC.A comparison of techniques was difficult because of heterogeneity; therefore, a network meta-analysis was not possible. All techniques have proved to be effective. The reported differences between the techniques were negligible. Therefore, a standard treatment for VVP could not be given according to this review.

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

Dataset Information

The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial).

Publications

The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial).

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