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 mostly targets women.
The IC Clinical Trials Group study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 studys end. 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 in the bladder is still a mystery, but research suggests 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 IC patients are able to work full time. The disorder accounts for $1.7 billion in lost wages and medical expenses. About a quarter of patients are younger than 30 years.
Anyone interested in joining the trial may contact study coordinators on the enclosed list. Clinics are 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 a quorum is reached earlier. Study results are expected to be available March 2004.
To learn more about IC, visit: http://www.niddk.nih.gov/health/urolog/pubs/cystitis/cystitis.htm or call the National Kidney and Urologic Diseases Information Clearinghouse at (800) 891-5390.
BCG and saline solutions for this study are provided by Organon Teknika, Durham, NC.