Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial—design and methods
Year: 2009
Type: article
Abstract: BACKGROUND: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. PURPOSE: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. METHODS: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. RESULTS: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. LIMITATIONS: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. CONCLUSION: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.
Source: Clinical Trials
Authors: John Wei, Ingrid Nygaard, Holly Richter, Morton Brown, Matthew Barber, Xiao Xu, Kimberly Kenton, Charles Nager, Joseph Schaffer, Anthony Visco, Anne Weber, for the Pelvic Floor Disorders Network
Institutions: University of Michigan, University of Utah, University of Alabama, Cleveland Clinic, Loyola University Chicago, Loyola Medicine, University of California San Diego, The University of Texas Southwestern Medical Center, Duke University, 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: G1967102714, Pelvic Floor Disorders Network Clinical Sites, G390348850, G4157666827, G4354517318, Cleveland Clinic Clinical Site, G5827047038, G6732265442, G6821603532, Pelvic Floor Disorders Network - Duke University Clinical Site, Clinical and Translational Resaerch in the Pelvic Floor Disorders Network
OpenAlex ID: W2060031073