Preventive Treatment with Diclofenac Suppositories May Improve BCG Induced Cystitis Symptoms without Affecting Its Oncologic Efficacy: A Prospective Double Blind Randomized Trial

Purpose: To evaluate whether prophylactic treatment with Diclofenac suppositories may relief bladder irritative symptoms following BCG irrigation, and to assess its effect on the oncologic outcome. Methods: A prospective, randomized, double-blind, placebo-control trial on 36 patients diagnosed with Non- Muscle Invasive Bladder Cancer (NMIBC) treated with induction installations of BCG. Patients received either a transrectal Diclofenac suppository (50 mg) or a placebo suppository immediately prior to and 24 hours after bladder irrigation. Following each irrigation patients completed a Quality of Life and a specific side effect questionnaire. Patients were thereafter followed prospectively for tumor recurrence. Results: For each irrigation, patients in the treatment group had statistically significant lower complains of dysuria (presented as the percent change from baseline; 473% vs. 161% in the control and treatment groups respectively, p=0.026). Other BCG side effects affected by the suppositories are reported. During a mean follow up of 22.8 month, 56% and 58% of patients in the treatment and control groups respectively had tumor recurrence (p=0.96). No significant side effects have been observed related to the study drug. Conclusion: Diclofenac suppositories are easy and safe to use and according to our results on this small study cohort, their use may suggest a beneficial effect in preventing complains caused by BCG induced cystitis without increasing tumor recurrence rate