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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. MD; Zyczynski, Halina MD; Rogers, Rebecca G. MD; Barber, Matthew D. MD; Richter, Holly E. PhD, MD; Visco, Anthony G. MD; Rardin, Charles R. MD; Harvie, Heidi MD; Wallace, Dennis PhD; Meikle, Susan F. MDfor the Pelvic Floor Disorders Network

Female Pelvic Medicine & Reconstructive Surgery: July/August 2016 - Volume 22 - Issue 4 - p 182–189
doi: 10.1097/SPV.0000000000000270
Original Articles

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.

In a randomized surgical trial for women with uterovaginal prolapse, the efficacy and safety of vaginal hysterectomy and uterosacral ligament suspension will be compared with a uterine conserving mesh hysteropexy.

From the *Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, CA; †Department of Obstetrics and Gynecology and Reproductive Sciences, University of Pittsburgh/ Magee Women-s Research Institute, Pittsburgh, PA; ‡Departments of Obstetrics and Gynecology and Surgery, University of New Mexico Medical Center, Albuquerque, NM; §Obstetric, Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, OH; ∥Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL; ¶Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC; **Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women's & Infants Hospital, Providence, RI; ††Department of Obstetrics and Gynecology, Hospital of University of Pennsylvania, Philadelphia, PA; ‡‡RTI International, Research Triangle Park, NC; and §§Gynecologic Health and Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.

Reprints: Charles W. Nager, MD, UC San Diego Health System 200 W. Arbor Dr. 8433 San Diego, CA 92103-8433. E-mail: cnager@ucsd.edu.

Conflicts of interest and source of funding: Drs. Nager, Zyczynski, Rogers, Barber, Richter, Visco, Rardin, Harvie, Wallace, and Meikle have no relevant conflicts of interest related to this work or manuscript.

Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development grants HD054214, HD069031, HD054215, HD069025, HD041261, HD041267, HD069006, HD069013, HD069010, and the National Institutes of Health Office of Research on Women's Health. Partial support for the PFDN SUPeR trial is being supplied by Boston Scientific Corporation through an investigator initiated grant to Dr. Wallace through the Pelvic Floor Disorders Network Data Coordinating Center.

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