PAPER

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

P Gallien¹, J-M Reymann², G Amarenco³, B Nicolas⁴, M de Sèze⁵, E Bellissant²

¹ Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire, Rennes, France
² Centre d’Investigation Clinique INSERM 0203, Unité de Pharmacologie Clinique, Centre Hospitalier Universitaire et Université de Rennes 1, Rennes, France
³ Service de Rééducation Neurologique et d’Explorations Périnéales, Hôpital Rothschild, Paris, France
⁴ Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes, Rennes, France
⁵ Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire, Bordeaux, France

Correspondence to:
Correspondence to:
Professor Eric Bellissant
Centre d’Investigation Clinique INSERM 0203, Unité de Pharmacologie Clinique, Centre Hospitalier Universitaire de Rennes et Université de Rennes 1, Hôpital de Pontchaillou, 2 rue Henri Le Guilloux, 35033 Rennes cedex, France; Eric.Bellissant{at}univ-rennes1.fr

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.

Abbreviations: EDSS, Expanded Disability Status Scale; IPSS, International Prostatism Symptom Score; SD, standard deviation

Keywords: botulinum toxin; detrusor sphincter dyssynergia; multiple sclerosis; urodynamics

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