THE EFFICACY OF INTRAVESICAL BACILLUS-CALMETTE-GUERIN IN THE TREATMENT OF INTERSTITIAL CYSTITIS - LONG-TERM FOLLOW-UP

Purpose: Interstitial cystitis is a severe debilitating bladder diseas e characterized by unrelenting pelvic pain and urinary frequency. A pr ospective, double-blind, placebo controlled study of the use of intrav esical bacillus Calmette-Guerin (BCG) in the treatment of interstitial cystitis was recently completed with a mean followup of 8 months. Res ults demonstrated a 60% BCG response rate, compared to a 27% placebo r esponse rate. We now report the long-term followup results of those pa tients who received intravesical BCG. Materials and Methods: Subjects randomized to receive BCC were followed at routine intervals with ques tionnaires and voiding diaries identical to those in the blinded study . Adverse events were closely monitored in the treatment and followup phases of the study. Subject baseline values were compared to followup data. Results: Of the BCG responders mean followup was 27 months (ran ge 24 to 33), and 8 of 9 (89%) continue to have an excellent response in all parameters measured. The global interstitial cystitis survey im proved 70%, daily voids decreased 31%, nocturia improved 54%, mean voi ded volume increased 61%, pelvic pain decreased 81%, vaginal pain decr eased 71%, urgency decreased 71% and dysuria decreased 82%. Overall we ll-being improved 54% and the Rand-36 quality of life survey overall i mproved 64%. In 86% of the patients (6 of 7) dyspareunia resolved. Of the initial BCG nonresponders there was no significant difference in i nterstitial cystitis symptomatology from baseline to last followup, su ggesting that BCG does not worsen interstitial cystitis symptoms. No l ong-term adverse events from BCG were noted. Conclusions: Intravesical Tice BCG is safe, effective and durable in the treatment of intersti tial cystitis. Of those patients who received only 6 weekly treatments and responded favorably 89% continue to have an excellent response wi th followup ranging from 24 to 33 months.