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

Author(s): Gallien P, Reymann JM, Amarenco G, Nicolas B, de Seze M, Bellissant E

Affiliation(s): Centre d'Investigation Clinique INSERM 0203, Unite de Pharmacologie Clinique, Centre Hospitalier Universitaire de Rennes et Universite de Rennes 1, Hopital de Pontchaillou, 2 rue Henri Le Guilloux, 35033 Rennes cedex, France.

Publication date & source: 2005-12, J Neurol Neurosurg Psychiatry., 76(12):1670-6.

Publication type: Multicenter Study; Randomized Controlled Trial

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.