Followup of Patients With Interstitial Cystitis Responsive to Treatment With Intravesical Bacillus Calmette-Guerin or Placebo

Purpose

We evaluated the longer term response in patients with interstitial cystitis who initially responded to intravesical bacillus Calmette-Guerin or placebo in a randomized clinical trial.

Materials and Methods

Patients with interstitial cystitis who responded positively to treatment with bacillus Calmette-Guerin or placebo after 34 weeks of followup in a double-blind clinical trial were followed for an additional 34 weeks in an observational study to assess response durability. Outcomes at 68 weeks included a patient reported global response assessment, 24-hour voiding diary, and pain, urgency and validated interstitial cystitis symptom indexes.

Results

Of responders to bacillus Calmette-Guerin or placebo in the clinical trial 38 continued extended followup in the observational study. A total of 12 (75%) responders who received placebo and 19 (86%) who received bacillus Calmette-Guerin considered themselves to remain moderately or markedly improved at week 68. Improved symptom outcomes were also generally maintained during followup in the 2 groups.

Conclusions

Most patients who respond to therapy with intravesical bacillus Calmette-Guerin or placebo maintain improved symptoms for up to 68 weeks after the initiation of therapy. However, initial response rates are low and placebo responders demonstrated essentially the same durability of response as bacillus Calmette-Guerin responders. These results argue against the routine use of bacillus Calmette-Guerin in this patient group.

Key Words: bladder, cystitis, interstitial, Mycobacterium bovis, pain, quality of life

Abbreviations and Acronyms: BCG, bacillus Calmette-Guerin, GRA, global response assessment, IC, interstitial cystitis, ICCTG, IC Clinical Trials Group, ICPI, O’Leary-Sant IC Problem Index, ICSI, O’Leary-Sant IC Symptom Index