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