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Interstitial Cystitis Clinical Trials Group/Research Network (ICCRN)History of NIDDK IC ResearchInterstitial cystitis (IC) is a chronic disorder, diagnosed primarily in women. The condition is characterized by pelvic pain associated with urinary frequency and urgency. Despite considerable effort, the etiology of IC has not been established. Although a large number of purported treatments are available, few rigorous, randomized clinical trials have been conducted to justify the use of many agents. The Interstitial Cystitis Clinical Research Network (ICCRN) was established by NIDDK's Division of Kidney, Urologic, and Hematologic Diseases to develop and conduct randomized clinical trials that evaluate novel therapies for IC. The network comprises 10 clinical centers and a data-coordinating center that provides expertise in protocol development, data analysis, quality control, and data management. NIDDK IC ResearchThe ICCRN is a product of two NIDDK programs: the Interstitial Cystitis Database (ICDB) Study and the Interstitial Cystitis Clinical Trials Group (ICCTG). Established in 1991, the ICDB was a five-year prospective cohort study of more than 600 men and women with symptoms of urinary urgency, frequency, and pelvic pain. The study described the longitudinal changes of urinary symptoms, the impact of IC on quality of life, treatment patterns, and the relationship between bladder biopsy findings and patient symptoms. The ICCTG was established in 1996 as a follow-up to the ICDB study. The clinical trials group developed two randomized, controlled clinical trials of promising therapies, one using oral therapies, pentosan polysulfate sodium (Elmiron®) and hydroxyzine hydrochloride (Atarax®) and the other administering intravesical treatment using Bacille Calmette-Guerin (BCG). BCG is a vaccine for tuberculosis that stimulates the immune system and may have an effect on the bladder. The ICCTG also developed and conducted ancillary studies of various biomarkers such as heparin-binding-growth-factor-like-growth-factor (HB-EGF) and anti-proliferative factor (APF). In 2003, the ICCTG became the Interstitial Cystitis Clinical Research Network (ICCRN), which will conduct additional clinical trials, either sequentially or concurrently, over a second five-year period. Ancillary studies will be developed and conducted in conjunction with the trials. ICCRN CentersCALIFORNIA, Stanford CANADA, Kingston, Ontario ILLINOIS, Maywood IOWA, Iowa City MARYLAND, Baltimore MASSACHUSETTS, Boston MICHIGAN, Detroit MICHIGAN, Royal Oak NEW YORK, Rochester PENNSYLVANIA, Philadelphia WASHINGTON, Seattle IC and Chronic ProstatitisBecause there is substantial commonality in the design and conduct of clinical trials for patients with interstitial cystitis and patients with chronic prostatitis, and because both involve chronic pelvic pain, investigators from the ICCRN and the Chronic Prostatitis Collaborative Research Network (CPCRN) will participate in an overarching organization, the Urological Pelvic Pain Collaborative Research Network (UPPCRN). Project Officer: Leroy Nyberg, M.D., Ph.D., 301-594-7717 Last Update: 9/15/2004 |
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