Female Pelvic Floor Disorders--Data Coordinating Center

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant) Pelvic floor disorders, including urinary incontinence, pelvic prolapse, and fecal incontinence, are common and significant health-related problems in the United States. Outcomes following surgical intervention for pelvic floor disorders have not been adequately evaluated. As a result, data necessary to fully inform patients and to make important policy decisions are unavailable. The long-term objective of the Clinical Trials Network for Female Pelvic Floor Disorders is to systematically evaluate these outcomes. This application to be the Data Coordinating Center (DCC) for the pelvic floor disorders network brings together experienced investigators from biostatistics, gynecology, urology, quality of life and health services research to prospectively assess the outcomes from various surgical interventions for female pelvic floor disorders using a novel design. The DCC will: 1. Provide expertise in the design of the studies to be performed by the network, 2. Provide expertise in the measurement of quality of life and in the selection of the instruments to assess treatment outcomes, 3. Provide expertise in the assessment of cost-effectiveness and in the development of the instruments to measure costs of alternative treatments, 4. Coordinate the implementation of the study protocols approved by the Steering Committee, including centralized database management with either centralized or remote data entry, 5. Monitor the sites with respect to data quality, and 6. Develop the plan for data analysis, perform the analysis and collaborate on the preparation of reports/publications that result from these studies. In this application the applicant proposes a randomized clinical trial to compare surgical procedures for pelvic organ prolapse. This design will provide valid comparisons of the surgical outcomes and allow for the prospective evaluation of the process of care, although surgeons will be able to specify the operative procedures that they are willing to perform. Since randomization may not be acceptable for all eligible subjects, either due to subject or surgeon preferences, the applicant proposes that the non-randomized, but eligible, subjects be enrolled into an observations study that, combined with the randomized subjects undergoing the same surgical procedure, enables the applicant to have greater numbers to evaluate factors that affect the success rate of a specific procedure. It is recognized that the Steering Committee will select the actual protocol to be implemented.