Research Updates in Kidney and Urologic Health

Clinical Trial Tests BCG for Interstitial Cystitis

Ten centers in the United States and Canada seek 260 patients to try a promising therapy for interstitial cystitis (IC), a chronic and painful bladder condition that affects mostly women.

The IC Clinical Trials Group study funded by the National Institute of Diabetes and Digestive and Kidney Diseases will test whether the bacterium Bacillus Calmette-Guérin (BCG) will relieve the pelvic pain and frequent urination that are hallmarks of IC. Participants will be randomly assigned to have either a BCG or saline solution temporarily placed in the bladder during each of six clinic visits. Neither doctors nor patients will know who received the BCG until the study ends. Patients whose symptoms are not relieved by the initial series will be openly offered BCG.

BCG is a vaccine for tuberculosis and a treatment for superficial bladder cancer. Exactly how BCG works is a mystery, but research suggests that it may stimulate a protective immune response and downplay a harmful one in the IC bladder. If BCG fulfills the promise of earlier studies, it could profoundly alter disease management and patients' quality of life, which has been described as worse than being on kidney dialysis. Symptoms are so severe that only about 50 percent of an estimated 1 million patients with IC are able to work full time. The disorder accounts for $1.7 billion in lost wages and medical expenses. About 25 percent of patients are younger than 30.

Those interested in joining the trial may contact the study coordinators (see below). Clinics are located in Baltimore; Boston; Detroit and Royal Oak, Michigan; Kingston, Ontario, Canada; Oklahoma City; Philadelphia; Rochester, New York; and Stanford, California. Coordinators want to enroll patients now but will continue recruiting through September 2002, unless the desired number is reached earlier. Study results are expected to be available in March 2004.

To learn more about IC, visit http://kidney.niddk.nih.gov/kudiseases/pubs/interstitialcystitis/index.htm or call the National Kidney and Urologic Diseases Information Clearinghouse at 1–800–891–5390.

BCG and saline solutions for this study are provided by Organon Teknika, Durham, NC.

IC Clinical Trial: Centers and Investigators

CALIFORNIA, Stanford
Stanford University Medical Center and Santa Clara Valley Medical Center
Christopher K. Payne, M.D.
Gilbert Rigaud, M.D.
Contact: 650–724–1753
Debra Clay, R.N., B.S.N.

CANADA, Kingston, Ontario
Queen's University
Alvaro Morales, M.D.
J. Curtis Nickel, M.D.
Contact: 613–548–6033
Laurel Emerson, R.N.
Joe Downey, B.Sc., M.Sc.

MARYLAND, Baltimore
University of Maryland
Toby Chai, M.D.
Susan Keay, M.D.
Richard Marvel, M.D.
John Warren, M.D.
Contact: 410–706–7560
Linda Horne and Theresa Jackson

MASSACHUSETTS, Boston
New England Medical Center
Erol Onel, M.D.
Grannum R. Sant, M.D.
Contact: 617–636–6317
Carolyn Shea-O'Malley, R.N.
Patricia Radgowski

MICHIGAN, Detroit
Henry Ford Hospital
David Burks, M.D.
Rifaat Dagher, M.D.
Contact: 313–916–8972
Michelle Peabody, R.N.
Jill Sullivan, R.N., B.S.N.

MICHIGAN, Royal Oak
William Beaumont Hospital
Ananias C. Diokno, M.D.
Kenneth Peters, M.D.
Contact: 248–551–0885
Eleanor Anton, R.N.

NEW YORK, Rochester
University of Rochester
Robert Mayer, M.D.
Edward M. Messing, M.D.
Contact: 716–275–0133
Kay Rust, R.N., M.S.N., N.P.
Elizabeth Smith, B.S.

OKLAHOMA, Oklahoma City
University of Oklahoma
Daniel J. Culkin, M.D.
James F. Donovan Jr., M.D.
Contact: 405–271–6900
Lynda Kelsey, R.N., M.S.
Karen Mataranglo, R.N.

PENNSYLVANIA, Philadelphia
University of Pennsylvania
George Drach, M.D.
Philip Hanno, M.D.
Eric Rovner, M.D.
Alan J. Wein, M.D.
Contact: 215–349–5874
Marilou Foy, R.N.
Gloria McNamara, R.N

Data Center, Philadelphia
University of Pennsylvania
J. Richard Landis, Ph.D.

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