A randomized trial of Prophylactic Uterosacral Ligament Suspension at the time of hysterectomy for Prevention of Vaginal Vault Prolapse (PULS): Design and methods

The primary aim of this randomized trial is to evaluate whether a standardized uterosacral ligament suspension colpopexy (USLSC), added to a planned hysterectomy for an indication other than pelvic organ prolapse (POP), decreases the rate of subsequent vaginal vault prolapse in women without preoperative symptomatic POP. Secondary aims include comparison of perioperative complications, urinary, bowel and sexual functions between subjects with and without concomitant USLSC. If shown to be beneficial, the cost-effectiveness of prophylactic USLSC at the time of hysterectomy will be evaluated. This trial will be performed at 4 centers across the United States. The data will be analyzed by the data-coordinating center of the Southern California Kaiser Permanente. Standardized questionnaires and objective measurements will be obtained. The patients and providers performing assessments are masked to treatment assignment The primary outcome, defined as absence of POP at/distal to the hymen on Pelvic Organ Prolapse Quantitative examination, will be determined 12 months post-operatively. Secondary outcomes include: no prolapse symptoms by questionnaires, and no treatment for POP besides the prophylactic study intervention. Additional follow-up occurs annually for a total of 5 years. Accrual is projected to take 3 years. Given cost and morbidity of surgical repair of post-hysterectomy prolapse, preventive strategies are of outmost importance. The risks and benefits of prophylactic USLSC have never been studied prospectively. This trial is designed to determine if USLSC is an appropriate clinical adjunct at the time of hysterectomy, with subsequent reduction of symptomatic POP. (C) 2013 Elsevier Inc. All rights reserved.