title: Placebo controlled, randomised, double blind study of the effects of botulinum A toxin on detrusor sphincter dyssynergia in multiple sclerosis patients.
abstract: 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.
authors.affiliation: 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.
authors.forename: P
authors.initials: P
authors.lastname: Gallien
authors.forename: J-M
authors.initials: JM
authors.lastname: Reymann
authors.forename: G
authors.initials: G
authors.lastname: Amarenco
authors.forename: B
authors.initials: B
authors.lastname: Nicolas
authors.forename: M
authors.initials: M
authors.lastname: de Sèze
authors.forename: E
authors.initials: E
authors.lastname: Bellissant
mesh_terms: D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications*; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D010919:Placebos; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000209:etiology; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology; D014563:Urodynamics
chemical_list: D009465:Neuromuscular Agents; D010919:Placebos; D019274:Botulinum Toxins, Type A