A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.

Abstract

PURPOSE:

We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC).

MATERIALS AND METHODS:

Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC, and reported at least moderate pain and frequency for a minimum of 6 months before study entry, were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34. Secondary outcomes included a 24-hour voiding diary, pain, urgency, validated IC symptom indexes and adverse events. The target sample size was 260 participants, designed to detect a difference in response rates between placebo and BCG of 30% and 50%, respectively.

RESULTS:

A total of 265 participants were randomized and 17 (6%) patients withdrew from study. The response rates for the primary outcome were 12% for placebo and 21% for BCG (p = 0.062). Small improvements were observed for all secondary outcomes, some more so with BCG, but these differences were of borderline statistical significance. Although a large number of adverse events were reported in the BCG arm, there was no statistically significant difference between the treatment arms in overall adverse event rates.

CONCLUSIONS:

Although the BCG safety profile was acceptable, the response rate for the primary outcome was low. Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive.

• Authors: Robert Mayer, Kathleen Joy Propert, Kenneth M Peters, Christopher K Payne, Yawei Zhang, David Burks, Daniel J Culkin, Ananias Diokno, Philip Hanno, J Richard Landis, Rosemary Madigan, Edward M Messing, J Curtis Nickel, Grannum R Sant, John Warren, Alan J Wein, John W Kusek, Leroy M Nyberg, Harris E Foster, Interstitial Cystitis Clinical Trials Group
• Journal: The Journal of urology (J Urol) Vol. 173 Issue 4 Pg. 1186-91 (Apr 2005) ISSN: 0022-5347 [Print] United States
• PMID: 15758738 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• BCG Vaccine
• Placebos

Topics

• Administration, Intravesical
• BCG Vaccine (administration & dosage, adverse effects, therapeutic use)
• Chronic Disease
• Cystitis, Interstitial (drug therapy, physiopathology)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Pain (physiopathology)
• Placebos
• Remission Induction
• Safety
• Treatment Outcome
• Urinary Bladder (physiopathology)
• Urination (physiology)