of the application) Interstitial cystitis (IC) is a chronic disease characterized by pain, urgency and frequency and by bladder findings of ulcers, glomerulations, and diminishe capacity. The etiology(ies) is unknown and numerous treatments have been examined but only a few in well-designed trials. Patients would benefit from scrutiny of existing and novel treatments, the mission of the IC Clinical Trials Group (IC CTG). Critical to the IC CTG is our ability to recruit IC patients for well designed clinical trials. Over the last 7 years, our work with IC patients has been to explore the pathogenesis of IC. We have discovered a urine peptide, which inhibits the growth of human bladder epithelial cells in vitro in 85% of IC patients vs. < 10% controls. To explore the clinical role of this peptide, we have recently begun a modest recruitment campaign and are surprised at the pent-up demand of IC patients and of urologists/gynecologists for IC research. Within a two month period, 241 patients have expressed willingness to participate in our clinical studies and 151 urologists/gynecologists have offered to refer us >500 IC patients for these studies. The Baltimore-Washington area comprises more than 6,000,000 people. This includes many IC patients and we will energetically work with the ICA and our network o urologists/ gynecologists to recruit large numbers of patients during our clinical trials. By a dedicated and patient centered clinical research enterprise, we will be jealous (sic) of each participant's continuation in our studies. To respond to this clinical opportunity, we have developed a multi-disciplinary team comprising veteran IC investigators, urologists, and urogynecologists, skilled in bladder diseases and pain syndromes. This team ha experience in complex projects, randomized placebo-controlled double-masked trials, large data sets, and collaborative ventures. This group will bring to the IC CTG experienced, motivated, and dedicated investigators; a new cadre of IC patients; and a network of referring urologists/gynecologists to study management strategies for this distressing disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK054125-03
Application #
6164567
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (J2))
Program Officer
Kusek, John W
Project Start
1998-05-10
Project End
2003-02-28
Budget Start
2000-03-01
Budget End
2001-02-28
Support Year
3
Fiscal Year
2000
Total Cost
$295,222
Indirect Cost
Name
University of Maryland Baltimore
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
003255213
City
Baltimore
State
MD
Country
United States
Zip Code
21201
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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
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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
Keay, S; Warren, J W; Zhang, C O et al. (1999) Antiproliferative activity is present in bladder but not renal pelvic urine from interstitial cystitis patients. J Urol 162:1487-9