The Loyola team plans to participate in the Clinical Trials Network in order to advance its understanding of the clinical care of women with pelvic floor disorders. The multi-disciplinary team has the volume and proven ability to participate in clinical trials. As requested in the RFA, a concept protocol is offered that studies clinically relevant aspects of the urinary continence mechanism in women with advanced pelvic organ prolapse. Specifically, the applicant proposes to compare routine versus selective urethropexy at the time of sacrocolpopexy in women with advanced pelvic organ prolapse (POP). This protocol will complement the ongoing, NIDDK trial which randomized genuine stress incontinence (GSI) patients to the Burch urethropexy versus the pubovaginal sling. Women with advanced POP are excluded from that trial, yet constitute a large number of affected patients. The applicant seeks to determine the efficacy and side effect rates for the Burch urethropexy in this setting. The concept protocol compares two common clinical methods of treatment in order to determine the optimal method. In addition, the applicant is planning to study the level of testing necessary to select the best protocol for the individual patient. Finally, the concept protocol will use the data from this clinical trials network to propose a standardized nomenclature to describe the status of the urinary continence status in women with advanced POP. Simply put, the concept protocol will: Determine which advanced POP patients need which urinary testing, if any; Determine the efficacy and side effects (across the whole pelvic floor) of routine versus selective Burch urethropexy; and Propose a data-based standardized nomenclature to describe the urinary continence status of women with advanced POP.
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