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)
Year: 2016
Type: article
Study design: Study Protocol
Abstract: OBJECTIVES: 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. METHODS: 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. RESULTS: Recruitment and randomization of 180 participants is complete, and participants are currently in the follow-up phase. CONCLUSIONS: 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.
Source: Urogynecology
Institutions: Cleveland Clinic, University of Pittsburgh, Brown University, UC San Diego Health System, University of Alabama at Birmingham, Magee-Womens Research Institute, Duke Medical Center, Women & Infants Hospital of Rhode Island, UAB Medicine, University of New Mexico Health Sciences Center, Hospital of the University of Pennsylvania, University of Pennsylvania, University of New Mexico, RTI International, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1222322107, Innovations in Treatments for Pelvic Floor Disorders: A Southwestern PFDN site, University of Alabama at Birmingham: Pelvic Floor Disorders Network, G4354517318, G4574270551, Pelvic Floor Disorders Network, Cleveland Clinic Clinical Site, G5418896253, Pittsburgh Pelvic Floor Research Program, G6069452013, Pelvic Floor Disorders Network Data Coordinating Center (U01), Brown/WIH Pelvic Floor Disorders Network Site, Pelvic Floor Disorders Network - Duke University Clinical Site, Pelvic Floor Disorders Network Clinical Site Application: The San Diego Pelvic Floor Consortium, Pelvic Floor Disorders Network, Pelvic Floor Disorders Network Data Coordinating Center, Duke University Medical Center (DUMC) Pelvic Floor Disorders Network (PFDN) Clinical Site, Brown/WIH Pelvic Floor Disorders Network Site
OpenAlex ID: W2337628636