The overall goal of this cooperative prospective cohort study is to assess the long-term outcomes of the most commonly utilized surgical interventions to correct urinary incontinence in adult women as well as the utilization of concomitant medical and behavioral therapy. More specifically, the aims of this cooperative study are to: design and develop a protocol, including diagnostic entry criteria, standardized diagnostic and outcome measures, and patient relevant outcomes; and conduct the observational study to assess the long-term outcomes of the selected surgical procedures. This proposal describes the role of the Biostatistical Coordinating Center (BCC) providing leadership and expertise in the following areas: (1) technical assistance with the design of the study, including development of the measurement battery, sample size estimates and power calculations, and entry criteria; (2) design of a Web-based distributed data management system for use by the Clinical Treatment Centers (CTCs); (3) quality control activities, including development of a Manual of Operations and forms, training and monitoring of CTC staff to ensure standard implementation of the protocol across sites; (4) monitoring of all data acquisition to ensure high quality data bases; (5) primary analyses of study outcomes; and (6) communication and meeting support. The NERI team of investigators offer the following: extensive experience with BCC activities in complex multi-site studies; an innovative Web- based data management system; tested and effective quality control procedures; experience with the development of condition-specific quality of life measures; and a highly experienced staff of statisticians with expertise in prospective cohort studies and clinical trials as well as techniques for longitudinal analyses and dealing with non-random? missing data. Expertise in urology, urogynecology and conservative therapies will be provided through a subcontract with Massachusetts General Hospital.
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