Botulinum a toxin and detrusor sphincter dyssynergia: a double-blind lidocaine-controlled study in 13 patients with spinal cord disease.
OBJECTIVE
To compare the efficacy and tolerance of botulinum A toxin (BTx) versus lidocaine (L), applied in the external urethral sphincter with a single transperineal injection in order to treat detrusor sphincter dyssynergia (DSD) in spinal cord injured patients.


METHODS
Thirteen patients (1F, 12 M) suffering from chronic urinary retention due to DSD were randomised to receive one transperineal injection of 100 IU BTx Botox degrees in 4 ml of 9% saline (botulinum group, (BG)) or 4 ml of 0.5% L (lidocaine group, (LG)). The main criteria of efficacy was post-voiding residual urine volume (PRUV), assessed three times daily on day one (D1), D7 and D30 after each injection. Other criteria were micturition diary, satisfaction score (SS), maximal urethral pressure (MUP), maximum detrusor pressure (DP) and type of DSD, recorded on D0 and D30.


RESULTS
In the BG, there was a significant decrease in PRUV (D7: -141.4 ml (p<0.03); D30: -159.4 ml (p<0.01)), in MUP (D30: -32 cm H(2)O, p<0.04) whereas no significant improvement was shown in the LG. SS was higher in BG than LG (p<0.02). DSD improved in BG whereas it remained unchanged in LG. All LG patients also received one injection of BTx on D30. They still presented improvement in PRUV and MUP 1 month later (D30'). Tolerance appeared satisfactory in both groups.


CONCLUSIONS
The preliminary results of this initial randomised double-blind study clearly demonstrated the superiority of BTx compared to L in improving clinical symptoms and urethral hypertonia associated with DSD in spinal cord injured patients.
de Sèze
Marianne
M
Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin Tastet-Girard, Bordeaux, France. madeseze@club-internet.fr
Petit
Hervé
H
Gallien
Philippe
P
de Sèze
Mathieu-Panchoa
MP
Joseph
Pierre-Alain
PA
Mazaux
Jean-Michel
JM
Barat
Michel
M
D000328:Adult; D000368:Aged; D000779:Anesthetics, Local / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy*
D000779:Anesthetics, Local; D009465:Neuromuscular Agents; D008012:Lidocaine; D019274:Botulinum Toxins, Type A