Trial reportFemale pelvic medicine & reconstructive surgery
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).
Trial report in Female pelvic medicine & reconstructive surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 26 citations in OpenAlex.
- Improved body image after uterovaginal prolapse surgery with or without hysterectomy.International urogynecology journal · 2022Trial
- 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.American journal of obstetrics and gynecology · 2021Trial
- Trial
- Vaginal morphology and position associated with prolapse recurrence after vaginal surgery: A secondary analysis of the DEMAND study.BJOG : an international journal of obstetrics and gynaecology · 2024Article
- Long-term Urinary Outcomes After Transvaginal Uterovaginal Prolapse Repair With and Without Concomitant Midurethral Slings.Female pelvic medicine & reconstructive surgery · 2022Article
- The impact of prior prolapse repairs on surgical outcomes with minimally invasive sacral colpopexy.International urogynecology journal · 2020Article
- Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse.Obstetrics and gynecology · 2020Article
- Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.Female pelvic medicine & reconstructive surgery · 2020Article
- Comparing laparoscopic and robotic sacrocolpopexy surgical outcomes with prior versus concomitant hysterectomy.International urogynecology journal · 2020Article
- Surgical Updates in the Treatment of Pelvic Organ Prolapse.Rambam Maimonides medical journal · 2017Review
- Comparison of the Quality of Life and Female Sexual Function Following Laparoscopic Pectopexy and Laparoscopic Sacrohysteropexy in Apical Prolapse Patients.Gynecology and minimally invasive therapyArticle
- Vaginal Uterosacral Ligament Suspension: A Retrospective Cohort of Absorbable and Permanent Suture Groups.Female pelvic medicine & reconstructive surgeryArticle
Corrections and comments
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Authors and funding
11 authors at 9 institutions in 1 country.
Funding
Abstract
objectivesWe 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.
methodsThe 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.
resultsRecruitment and randomization of 180 participants is complete, and participants are currently in the follow-up phase.
conclusionsThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.