Followup Of Patients With Interstitial Cystitis Responsive To Treatment With Intravesical Bacillus Calmette Guerin Or Placebo

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Mar 2008 - 0:00 PDT

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UroToday.com - The Interstitial Cystitis Clinical Trials Group (ICCTG) recently reported the results of a randomized, double-blind, placebo controlled clinical trial of intravesical bacillus Calmette-Guerin (BCG). After 34 weeks of follow-up, there was no statistically significant difference between BCG and placebo in the rate of responders based on a global response assessment. Propert and colleagues from the ICCTG now report the results of an observational study of the subset of participants who responded to BCG or placebo, to determine whether the effects persisted. These patients remained blinded to their original treatment assignment throughout long-term follow-up.

Thirty-eight of the 44 responders in the clinical trial participated in the observational study. Of 16 responders, 12 (75%) from the placebo arm and 19 of 22 from the BCG arm (86%) considered themselves to have remained moderately or markedly improved by the global response assessment at week 68. This included 6 patients from the placebo arm and 13 from the BCG arm who reported that they remained markedly improved. There was no statistically significant difference between the 2 arms.

These long term responses in the BCG and placebo arm are provocative, Propert notes, in that it is distinctly unusual to see long-lasting, dramatic symptom improvement in such refractory cases in the absence of specific therapy. The Held study of 20 years ago suggested, based on patient recollection, that up to 50% of patients experience remissions lasting a mean of 8 months at some time in their course1 that are unrelated to treatment, and it is possible that this is what is being observed by this fascinating study. The initial placebo response was only 12%. The authors point out the importance of including a placebo arm in clinical trials of interstitial cystitis, as is illustrated by the results of this study.

Propert KJ, Mayer R, Nickel JC, Payne CK, Peters KM, Teal V, Burks D, Kusek JW, Nyberg LM, Foster HE; Interstitial Cystitis Clinical Trials Group

Journal of Urology, 179:552-555, 2008.

Reported by UroToday.com Contributing Editor Philip M. Hanno, MD, MPH Professor of Urology Division of Urology, Department of Surgery Hospital of the University of Pennsylvania Medical Director Department of Clinical Effectiveness and Quality Improvement University of Pennsylvania Health System Philadelphia, PA

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