Pelvic floor disorders, such as urinary incontinence, pelvic organ prolapse, and fecal incontinence, are common and significant health-related problems for women in the United States. Outcomes following surgical and non-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 Pelvic Floor Disorders Network (PFDN) 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, urogynecology, urology, quality of life and health services research to prospectively assess the outcomes from various surgical interventions for female pelvic floor disorders.
The specific aims of the DCC are to: 1. Assist in protocol development by providing expertise in the design, conduct and analysis of clinical trials conducted by the PFDN. 2. Provide expertise in measurement of quality of life and in the selection of the appropriate instruments to assess treatment outcomes and, when appropriate, to perform the interviews. 3. Coordinate the implementation of the study protocols approved by the Steering Committee, including design of the case report forms and interviewing protocols, development of a manual of operations, centralized database management with either centralized or remote data entry, submission of an IND to the FDA when necessary, and by organizing training and certification sessions, as needed. 4. Establish a database for each study conducted by the PFDN. 5. Implement either centralized or web-based data entry and verification. 6. Monitor the clinical sites with respect to data quality. 7. Provide infrastructure for monitoring adverse events and regulatory oversight for the network. 8. Provide logistical support for the Steering Committee, Advisory Board and DSMB, for both face-to-face meetings and teleconferences. 9. Maintain a website for the PFDN that includes web pages with content for the public, and a password- protected site with all study documentation and databases. 10. Manage and distribute protocol funds to the Clinical Centers. To illustrate the work of the DCC, a randomized clinical trial is proposed to compare surgical procedures for pelvic organ prolapse using a vaginal approach. ? ? ?
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