of the application) The specific objectives of this proposal are: 1) Study the safety and efficacy of various treatments for Interstitial Cystitis (I.C.); 2) Collect uniform demographic and diagnostic information on patients being evaluated and treated for interstitial Cystitis, before and after therapy; 3) Collect clinical samples (urine, blood), which relate to the specific treatment utilized; 4) Transmit data and send clinical results to a central Data Coordination Center for analysis. The overall goal of this proposal is to conduct double-blind, parallel, randomized controlled clinical trials to determine the safety and efficacy of oral and intravesical therapies for Interstitial Cystitis. L-Arginine orally) and Heparin (intravesically) were selected because they hav been reported as efficacious agents with minimal side effects in the treatment of I.C. symptoms. During phase one we will participate in steering Committee planning and development of study protocols and data instruments. Years two through five we will conduct clinical trials potentially in parallel. In conjunction with Dr. Philip Hanno (Chief of Urology, Division of Urology, Temple University, Philadelphia, PA) and Dr. Kristene Whitmore (Chief of Urology, Allegheny University/ Graduate, Philadelphia, PA), specific objective 2, 3, and 4 have been accomplished as part of our ongoing joint studies on Interstitial Cystitis. The Philadelphia team has demonstrated the ability to work together and form an exceptionally efficient network for I.C. patients across a large geographical area. This group's constant interaction creates a solid professional alignment that benefits patients from near and far.
|Propert, Kathleen Joy; Mayer, Robert; Nickel, J Curtis et al. (2008) Followup of patients with interstitial cystitis responsive to treatment with intravesical bacillus Calmette-Guerin or placebo. J Urol 179:552-5|
|Keay, Susan; Reeder, Jay E; Koch, Kristopher et al. (2007) Prospective evaluation of candidate urine and cell markers in patients with interstitial cystitis enrolled in a randomized clinical trial of Bacillus Calmette Guerin (BCG). World J Urol 25:499-504|
|Propert, Kathleen Joy; Mayer, Robert; Nickel, J Curtis et al. (2007) Did patients with interstitial cystitis who failed to respond to initial treatment with bacillus Calmette-Guerin or placebo in a randomized clinical trial benefit from a second course of open label bacillus Calmette-Guerin? J Urol 178:886-90|
|Nickel, J Curtis; Tripp, Dean; Teal, Valerie et al. (2007) Sexual function is a determinant of poor quality of life for women with treatment refractory interstitial cystitis. J Urol 177:1832-6|
|Propert, K J; Mayer, R D; Wang, Y et al. (2006) Responsiveness of symptom scales for interstitial cystitis. Urology 67:55-9|
|Mayer, Robert; Propert, Kathleen Joy; Peters, Kenneth M et al. (2005) A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis. J Urol 173:1186-91|
|Sant, G R; Propert, K J; Hanno, P M et al. (2003) A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. J Urol 170:810-5|