Interstitial Cystitis Clinical Trials Group/Research Network (ICCRN)
History of NIDDK IC Research
Interstitial 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 Research
The 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.
Stanford University Medical Center
Christopher K. Payne, M.D.
Rajesh Shinghal, M.D.
Rodney U. Anderson, M.D.
Debra Clay, R.N., B.S.N.
CANADA, Kingston, Ontario
J. Curtis Nickel, M.D.
Alvaro Morales, M.D.
Laurel Emerson, R.N., CCRP
Joe Downey, M.Sc., CCRP
[JD] (613) 533-2894
Loyola University Medical Center
Mary Pat Fitzgerald, M.D.
Linda Brubaker, M.D.
Elizabeth Wengel, M.S., R.N.
IOWA, Iowa City
University of Iowa
Karl J. Kreder, M.D.
Michael O'Donnell, M.D.
Mary Eno, R.N.
University of Maryland
Toby Chai, M.D.
Susan Keay, M.D.
Lisa C. Radebaugh, CRNP, CUNP
Tufts Univ. School of Medicine -
New England Medical Center
Erol Onel, M.D.
Grannum R. Sant, M.D.
T.C. Theoharides, Ph.D., M.D.
Carolyn Shea-O'Malley, R.N.
Henry Ford Hospital
David Burks, M.D.
Rifaat Dagher, M.D.
Michelle Peabody, R.N.
Jill Sullivan, R.N., B.S.N.
MICHIGAN, Royal Oak
William Beaumont Hospital
Kenneth Peters, M.D.
Eleanor Anton, R.N.
NEW YORK, Rochester
University of Rochester
Robert Mayer, M.D.
Edward M. Messing, M.D.
Kay Rust, R.N., M.S.N., F.N.P.
Elizabeth M. Smith, B.S.
University of Pennsylvania
Philip Hanno, M.D.
Diane K. Newman, R.N.C., M.S.N., CRNP
Lilliam Ribeiro, B.S.
University of Washington
Richard E. Berger, M.D.
Charles H. Muller, Ph.D., HCLD
Elizabeth A. Miller, M.D.
Jane Miller, M.D.
IC and Chronic Prostatitis
Because 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