Leclaire EL, et al. - Whether or not adding a belladonna and opiate (BO) suppository to standard lidocaine instillation resulted in reduction of bladder injection pain during onabotulinum toxin A (BTX-A) injection procedure was investigated. Researchers noted no significant reduction in bladder injection pain, or increase in risk of urinary retention immediately post-procedure or two weeks later with BO suppository use. A high satisfaction was observed with pain control among BTX-A injection patients.

Methods

• Researchers performed a prospective, randomized, double-blind, placebo-controlled study including patients undergoing BTX-A bladder injection at a single clinic.
• Patients were eligible to participate if: 18 years or older, met clinical criteria for invasive treatment of refractory urinary symptoms, had previously documented post-void residual (PVR) volumes less than 150ml, and elected for in-office intravesical BTX-A injection.
• By computer generated block randomization, they randomized participants to receive a BO (belladonna alkaloid with morphine 16.2/7.5mg) or placebo suppository.
• In all participants, suppositories were placed immediately prior to lidocaine-based anesthesia,.
• A standardized injection procedure using the same rigid cystoscope, needle type, and injection pattern was performed on all participants (20 injections total).
• Using a 0-10 numeric rating scale, they determined pain intensity 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).
• Using the difference between PA and P10, they calculated pain increase during procedure.
• Immediately post-procedure and two weeks later, measurement of PVR was performed.
• A Likert scale was used to measure patient satisfaction with pain control.
• Change in pain level from anesthetic baseline to mid-procedure (P10-PA) was assessed as primary outcome measure.
• In this study, a final sample size of 26 patients was needed to have 80% power (alpha = 0.05) to detect a 50% reduction in bladder injection pain during the procedure as defined by the primary outcome.
• All analyses were performed using an intent-to-treat approach.

Results

• Researchers enrolled and randomized 26 participants with 13 in each study arm.
• Participants in the treatment group compared to those in the placebo group were slightly older (p=0.05); no statistically significant differences were noted in terms of medical comorbidities.
• Median P10-PA was 4 (range 1,10) and 5 (range 0,9) for the placebo group and treatment group, respectively (p=0.94).
• For the placebo group and treatment group, median P20 scores were 3 (range 0,10) and 2 (range 0,8), respectively (p=0.29).
• No significant differences were noted in pre-injection pain scores reported at P0 and PA.
• Five (38%) of the placebo group and 3 (23%) of the treatment group showed post-procedure PVR greater than 200ml (p=0.67).
• Findings showed two week post-procedure PVR greater than 200ml in 3 (25%) of the placebo group and 2 (15%) of the treatment group (p=0.64) for an overall rate of 20%.
• In each group, 11 (84%) participants reported being “mostly satisfied” or “very much satisfied” with pain control.