Placebo controlled, randomised, double blind study of the effects of botulinum A toxin on detrusor sphincter dyssynergia in multiple sclerosis patients

Objective: The purpose of the study was to evaluate the efficacy and safety of botulinum A toxin in the treatment of detrusor sphincter dyssynergia in multiple sclerosis patients. Methods: This was a multicentre, placebo controlled, randomised, double blind study. Patients with chronic urinary retention were included if they had post-voiding residual urine volume between 100 and 500 ml. They received a single transperineal injection of either botulinum A toxin ( 100 U Allergan) or placebo in the sphincter and also 5 mg slow release alfuzosin bid over 4 months. Main endpoint was post-voiding residual urine volume assessed 1 month after injection. Follow up duration was 4 months. Statistical analysis was performed using a sequential method, the triangular test. Results: The study was stopped after the fourth analysis ( 86 patients had been included: placebo: 41, botulinum A toxin: 45). At inclusion, there was no significant difference between groups whichever variable was considered. Mean ( standard deviation) post-voiding residual urine volume was 217 ( 96) and 220 ( 99) ml in placebo and botulinum A toxin groups, respectively. One month later, post-voiding residual urine volume was 206 ( 145) and 186 ( 158) ml ( p = 0.45) in placebo and botulinum A toxin groups, respectively. However, compared to placebo, botulinum A toxin significantly increased voiding volume (+ 54%, p = 0.02) and reduced pre-micturition ( -29%, p = 0.02) and maximal (-21%, p = 0.02) detrusor pressures. Other secondary urodynamic endpoints and tolerance were similar in the two groups. Conclusions: In multiple sclerosis patients with detrusor sphincter dyssynergia, a single injection of botulinum A toxin ( 100 U Allergan) does not decrease post-voiding residual urine volume.