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

Gallien, P.; Reymann, J.-M.; Amarenco, G.; Nicolas, B.; de Sèze, M.; Bellissant, E.
December 2005
Journal of Neurology, Neurosurgery & Psychiatry;Dec2005, Vol. 76 Issue 12, p1670
Academic Journal
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.


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