Meta- analysis of BCG therapy showed improvement in symptoms according to the Wisconsin Interstitial Cystitis Symptom Inventory , but no difference in 24-h urinary frequency .
Conclusions Meta- analysis showed an improvement exclusively of the symptoms as measured by the Wisconsin Interstitial Cystitis Inventory , but not in 24-h urinary frequency , with BCG therapy .
Introduction and hypothesisThe objective of the study was to assess the effectiveness of intravesical treatment for painful bladder syndrome ( PBS ) .
A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.
PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S 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 r and omized 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 , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized 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
Meta- analysis of BCG therapy showed improvement in symptoms according to the Wisconsin Interstitial Cystitis Symptom Inventory , but no difference in 24-h urinary frequency .
Conclusions Meta- analysis showed an improvement exclusively of the symptoms as measured by the Wisconsin Interstitial Cystitis Inventory , but not in 24-h urinary frequency , with BCG therapy .
Introduction and hypothesisThe objective of the study was to assess the effectiveness of intravesical treatment for painful bladder syndrome ( PBS ) .