Evaluate the Efficacy of Intravesical Bacillus Calmette Guerin (BCG), for the Treatment of Interstitial Cystitis (IC)

The ICCTG RCT2 study was a randomized, placebo-controlled, two-arm clinical trial that investigated the efficacy and safety of intravesical Bacillus Calmette-Guerin (BCG) therapy in treating patients with treatment refractory Interstitial Cystitis (IC). IC is a bladder syndrome characterized as painful, debilitating and chronic, with no widely accepted effective treatment. Characteristic symptoms include pain with bladder filling, and marked urinary frequency (to relieve pain). The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.

Subjects with IC 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 recorded in a diary. Although the safety profile for BCG was acceptable, the therapy did not show significant benefit compared to placebo.