The goal of the Pelvic Floor Disorders Network (PFDN) is to identify optimum diagnosis and management strategies for women with pelvic floor disorders (PFD) using the highest quality research methods available. The Cleveland Clinic offers a stable academic and research-oriented environment for the conduct of PFDN studies including experienced investigators with complementary clinical and research backgrounds that have a particular interest and a successful history of conducting clinical trials evaluating both surgical and nonsurgical therapies for women with PFD.
The specific aims of this application are: 1) to demonstrate that the Cleveland Clinic (CC) Clinical Site has contributed substantially to the academic, administrative, and clinical aspects of the PFDN since joining in its 2nd 5-year cycle;that it possesses the personnel, patient, clinical and administrative resources needed for successful participation;and that continued participation would be advantageous to the successful attainment of the Network's scientific goals and 2) to present a concept proposal for potential conduct by the PFDN. We propose evaluating the comparative effectiveness of sacrospinous hysteropexy (SSH), the most well-studied uterine-sparing pelvic organ prolapse (POP) surgery, relative to total vaginal hysterectomy with sacrospinous ligament fixation (TVH/SSLF), a commonly used hysterectomy-based vaginal uterovaginal prolapse procedure.
The specific aims of the concept proposal are: 1) compare the anatomic, functional, sexual and health-related quality of life outcomes of SSH to TVH/SSLF in women undergoing surgery for Stage 2-4 POP uterovaginal prolapse 2 years after surgery;2) compare surgical recovery and short- and long-term morbidity of SSH and TVH/SSLF in these same women and 3) determine the incremental cost-effectiveness of SSH compared to TVH/SSLF for the treatment of Stage 2-4 POP. Enrolled subjects will be randomized in the operating room on the day of surgery to receive either SSH or TVH/SSLF (1:1) using a random permutated block design. Randomization will be stratified by surgeon to account for the varying experience and expertise. Subjects and study coordinators will be blinded to treatment assignment until completion of the study.
Nearly one quarter of all women report symptoms of at least one PFD, including prolapse. POP is the most common indication for hysterectomy in postmenopausal women and it is unknown whether the addition of hysterectomy to POP surgery is integral to successful surgical outcome. The results of our concept proposal could justify or eliminate the need for as many as 70,000 hysterectomies in the US each year.
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