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.
Gallien
P
P
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.
Reymann
J-M
JM
Amarenco
G
G
Nicolas
B
B
de Sèze
M
M
Bellissant
E
E
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
D009465:Neuromuscular Agents; D010919:Placebos; D019274:Botulinum Toxins, Type A