Pelvic floor disorders (PFD) including urinary incontinence, pelvic organ prolapse (POP), and fecal incontinence affect a substantial proportion of women in the U.S. PFD result in significant psychosocial costs to an individual and their aggregate social and economic costs to society are enormous. Despite their substantial health impact, the quality of the evidence supporting most of the commonly used treatments, especially surgical interventions, is limited by the lack of standardization of diagnostic and therapeutic interventions, use of non-standardized and non-validated outcome measures, poor quality research designs, and inadequate power to detect clinically meaningful differences. The long-term objective of the Pelvic Floor Disorders Network (PFDN) is to identify optimum diagnosis and management strategies for women with PFD using the highest quality research methods available.
The specific aims of this application are: 1) to demonstrate that the Cleveland Clinic Foundation (CCF) possesses the personnel, patient, clinical, and administrative resources needed for successful participation as a Clinical Site in the PFDN; and that our participation would be advantageous to the successful attainment of the Network's scientific goals and 2) to present a concept application for potential conduct by the PFDN. The broad, long-term objectives of our concept application are 1) to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault fixation (USWS) and 2) to assess the role of perioperative pelvic floor physiotherapy (PFPT) in women undergoing transvaginal surgery for apical or uterine POP.
Our Specific aims are to: 1) compare the anatomic outcomes of SSLF to USWS in women undergoing transvaginal surgery for Stage 2-4 POP involving the vaginal apex or uterus 3 years after surgery;2) compare functional, sexual, and health-related quality of life (HRQOL) outcomes of SSLF to USWS in the same women 3 years after surgery; 3) assess whether short-term functional, sexual, and HRQOL outcomes improve in women receiving PFPT perioperatively compared to those who receive surgery alone; 4) assess whether perioperative PFPT improves anatomic, functional, sexual and HRQOL outcomes 3 years after surgery (long-term) compared to surgery alone and 5) determine the incremental cost-effectiveness of perioperative PFPT at the time of transvaginal surgery for POP. We present a collaborative multi-centered randomized trial comparing SSLF to USSVS with or without perioperative PFPT using a 2x2 factorial study design. A standardized common protocol for enrollment, treatment and data collection will be employed by 6-8 Clinical Sites within the PFDN coordinated by the data coordinating center. ? ? ? ?
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