Creating Public Use Datasets for PFDN Surgical Trials

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Project Summary The Pelvic Floor Disorders Network (PFDN) was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in 2001 to conduct collaborative research and improve clinical care for women with PFDs including pelvic organ prolapse (POP), stress and urgency urinary incontinence (UI), and fecal incontinence (FI). The Colpopexy and Urinary Reduction Effort (CARE) trial, the Pelvic Support, Pelvic Symptoms, and Patient Satisfaction after Colpocleisis (Colpocleisis) study, and the Outcomes following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) trial are three studies involving surgical POP repair that were completed during the first two funding cycles of the PFDN (2001-June 2011). The CARE and OPUS trials evaluated whether anti-incontinence surgeries performed at the time of POP repair were effective in preventing new-onset stress UI (SUI). The Colpocleisis study assessed clinical and quality of life outcomes following prolapse repair with a colpocleisis procedure, and some study participants also underwent concomitant SUI surgery. The results of these studies have been published, but comprehensive datasets and documentation are not available to researchers outside of the Network. Meanwhile, these data remain highly valuable to researchers, particularly in light of the ongoing debate about the relative safety and efficacy of surgeries involving mesh devices spurred by the 2008 Food and Drug Administration (FDA) Public Health Notificationregarding complications associated with transvaginal placement of mesh to treat POP and SUI. These three studies include data on a range of surgical procedures used to treat POP and SUI, with and without mesh devices, and using abdominal and vaginal approaches. If these data were available to researchers, they would enable analyses that could help fill important knowledge gaps, including those regarding the safety and efficacy of surgeries performed with older mesh devices compared to devices on the market today. The data resulting from CARE, Colpocleisis, and OPUS represent a valuable resource; however, for these studies which were completed during the tenure of the previous PFDN data coordinating center (DCC), data are not publicly available, and creating public use datasets does not fall within the scope of work for the current DCC. Therefore, as the DCC for the PFDN since July 2011, RTI International proposes to achieve the following specific aims using funding available through PAR-16-149 Archiving and Documenting Child Health and Human Development Data Sets (R03): (1) creating public use datasets and documentation for the CARE, Colpocleisis, and OPUS studies , (2) harmonizing the data to facilitate analyses that make use of data from multiple studies, and (3) sharing the public use datasets and documentation through the NICHD Data and Specimen Hub (DASH).