The specific aims of this proposal are to establish the Division of Urology, the Medical College of Wisconsin as a clinical center of excellence for the multi-institutional NIDDK trial entitled """"""""Minimally Invasive Surgical Therapies Treatment Consortium for Benign Prostatic Hyperplasia."""""""" The planning for this clinical trial center has been performed to ensure the center?s success in meeting the long-term objectives of the multi-center trial. Specifically, this proposal provides detailed information to establish our ability to meet recruitment goals including minority populations. The following sections outline fail-safe mechanisms in this center design to ensure patient eligibility, data accuracy and efficient data reporting. Two additional considerations central to the design of this clinical center have been the need to maintain patient compliance throughout the duration of enrollment and follow-up, and the need to communicate effectively with the Biostatistical Coordinating Center for this multi-institutional trial. These tasks will be performed in a timely, efficient, accurate and professional manner to ensure the validity of the data contributed to the trial. This, together with similar contributions from the other clinical trial centers, should allow the test hypothesis to be answered, specifically to evaluate the safety and long-term efficacy of minimally invasive therapies for lower urinary tract symptoms. Our study center will participate as members of a group of investigators who will conduct multiple randomized clinical trials, either sequentially or concurrently, of minimally invasive devices for the treatment of symptomatic BPH. The investigators from this study center will develop clinical trials and carry out these trails in accordance with centrally approved protocols. The study center at the Medical College of Wisconsin will enroll 180 patients in this clinical trial. The recruitment and marketing strategies outlined in the following sections will ensure this level of participation as well as maximize the center?s ability to recruit minority populations. The center has been designed to provide all the clinical, laboratory and follow-up data required in the protocol. In summary, this proposal outlines what we believe to be the outstanding credentials of the Division of Urology, the Medical College of Wisconsin to serve as a clinical center in this multi-institutional trial.
| Crawford, E David; Hirst, Kathryn; Kusek, John W et al. (2011) Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol 186:965-70 |
