Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods

John Wei, Ingrid Nygaard, Holly Richter, Morton Brown, Matthew Barber, Xiao Xu, Kimberly Kenton, Charles Nager, Joseph Schaffer, Anthony Visco, Anne Weber, Mathew D. Barber, Marie Fidela Paraisor, Mark D. Walters, J. Eric Jelovsek, Firouz Daneshgari, Linda McElrath, Donel Murphy, Cheryl Williams, Anthony G. ViscoJennifer Wu, Alison Weider, Cindy Amundsen, Mary J. Loomis, Linda Brubaker, Kimberly Kenton, MaryPat P. FitzGerald, Elizabeth Mueller, Kathy Marchese, Mary Tulke, Holly E. Richter, R. Edward Varner, Robert L. Holley, Thomas L. Wheeler, Patricia S. Goode, L. Keith Lloyd, Alayne D. Markland, Velria Willis, Nancy Saxon, LaChele Ward, Lisa S. Pair, Charles W. Nager, Shawn A. Menefee, Emily Lukacz, Karl M. Luber, Michael E. Albo, Margie Kahn, Lysa Woodall, Giselle Zazueta-Damian, Morton B. Brown, Cathie Spino, John T. Wei, Beverly Marchant, Donna DiFranco, John O L DeLancey, Dee Fenner, Nancy K. Janz, Wen Ye, Zhen Chen, Yang Wang Casher, Joseph Schaffer, Clifford Wai, Marlene Corton, Gary Lemack, Kelly Moore, David Rahn, Amanda White, Shanna Atnip, M. Hull Margaret, Pam Martinez, Deborah Lawson, Ingrid Nygaard, Peggy Norton, Linda Freeman, Anne M. Weber, Susan Meikle

Research output: Contribution to journalArticle

30 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)162-171
Number of pages10
JournalClinical Trials
Volume6
Issue number2
DOIs
StatePublished - 2009

ASJC Scopus subject areas

  • Pharmacology

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    Wei, J., Nygaard, I., Richter, H., Brown, M., Barber, M., Xu, X., Kenton, K., Nager, C., Schaffer, J., Visco, A., Weber, A., Barber, M. D., Paraisor, M. F., Walters, M. D., Jelovsek, J. E., Daneshgari, F., McElrath, L., Murphy, D., Williams, C., ... Meikle, S. (2009). Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial - Design and methods. Clinical Trials, 6(2), 162-171. https://doi.org/10.1177/1740774509102605