Faculty of the University of Pittsburgh School of Medicine Departments of Urology and Obstetrics and Gynecology has formed a collaborative urinary incontinence program. Our health care system with over 25 hospitals and outpatient facilities is an outstanding resource for research subject recruitment. Our proven ability to hold leadership positions in NIH sponsored multicenter surgical trials and to perform a large number of bladder suspension operations per year make us valuable contributors to the Urinary Incontinence Treatment Network (UITN). Dr. Chancellor, the principal investigator [P.I.], was funded by the NIH as PI in 1994-1998 to run a multicenter prospective randomized study between sphincterotomy and sphincter stent in spinal cord injured patients. This involved a complex surgical trial at four major spinal cord injury centers. The study was successfully finished with complete recruitment. The results were published in the Journal of Urology [Appendix 1]. In addition, Dr. Halina Zyczynski [Co-P.I.], who is the director of the Urogynecology Program at Magee-Womens Hospital, has developed a large pelvic floor dysfunction treatment program. Together, Urogynecology and Urology performed 357 stress incontinence operations this past year. We propose a protocol that prospectively compares non-invasive history exam with urodynamic evaluation. The patients will then be randomized to either the pubovaginal sling or the Burch procedure. Coexisting detrusor instability (DI) will not be treated preoperatively to determine its outcome after surgery. Persistent or denovo DI at 12 weeks will be randomized to pharmaceutical or behavioral intervention. Urodynamics studies will be performed 12 months postoperative. We are committed to adhering to the final protocol of UITN upon the activation of this grant. In conclusion we are enthusiastic about this RFA. All five investigators are experienced surgeons with similar techniques for both incontinence operations. We believe we have the unique resources and talent to become successful contributing members of the UITN.
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