15: Randomized controlled trial of belladonna and opiate suppository during intradetrusor onabotulinum toxin-A injection

Abstract

Intradetrusor onabotulimun toxin A (BTX-A) injection can be performed in the doctor’s office under local anesthesia. We aimed to evaluate the effectiveness of belladonna and opiate (BO) suppository in adjunct to standard anesthesia for in-office BTX-A treatment. We hypothesized the addition of a BO suppository would reduce bladder injection pain. This was a prospective, randomized, double-blind, placebo-controlled study of patients undergoing BTX-A bladder injection at a single clinic. Participants were randomized by computer generated block randomization to receive a BO (belladonna alkaloid with morphine 16.2/7.5 mg) or placebo suppository. Suppositories were placed immediately prior to lidocaine-based anesthesia, which all participants received. All participants underwent a standardized injection procedure using the same rigid cystoscope, needle type, and injection pattern (20 injections total). Participants reported bladder pain using a 0-10 numeric rating scale. Pain scores were obtained before anesthesia and suppository (P0), 40 minutes after administration of anesthesia and suppository (PA), after first 10 bladder injections (P10), and immediately after completion of 20 injections (P20). Pain increase during procedure was calculated using the difference between PA and P10. Post void residuals (PVRs) were measured immediately post-procedure and two weeks later. Patient satisfaction with pain control was measured using a Likert scale. Our primary outcome was change in pain level from anesthetic baseline to mid-procedure (P10-PA). Secondary outcomes were PVR >200 mL and satisfaction with pain control. A needed sample size of 26 was calculated in order to detect a 50% difference in P10-PA with 80% power. Categorical variables and median pain scores were compared using Fisher’s exact and Kruskal-Wallis tests, respectively. An intent-to-treat approach was used for all analyses. Twenty-six participants were enrolled and randomized with 13 in each study arm. One participant was lost to follow-up. There were no statistically significant differences in demographic variables or medical comorbidities between the groups. Median P10-PA for the placebo group and treatment group was 4 (range, 1-10) and 5 (range, 0-9), respectively (p = 0.94). Median P20 scores for the placebo group and treatment group were 3 (range, 0-10) and 2 (range, 0-8), respectively (p = 0.29). There were no significant differences in pre-injection pain scores reported at P0 and PA. Post-procedure PVR >200 mL was noted in 5 (38%) of the placebo group and 3 (23%) of the treatment group (p = 0.67). Two-week post-procedure PVR >200 mL was noted in 3 (25%) of the placebo group and 2 (15%) of the treatment group (p = 0.64) for an overall rate of 20%. Eleven (84%) participants in each group reported being “mostly satisfied” or “very much satisfied” with pain control. Addition of BO suppository to standard lidocaine-based anesthesia provided no added benefit to significantly reduce bladder injection pain. Suppository use did not increase risk of urinary retention immediately post-procedure or two weeks later. Satisfaction with pain control among BTX-A injection patients is high.