Efficacy and impact of botulinum toxin A on quality of life in patients with neurogenic detrusor overactivity: a randomised, placebo-controlled, double-blind study.
OBJECTIVE
To evaluate the effect of a single injection of 500 U of botulinum toxin A (BTX-A; Dysport) on use of oral rescue medication, bladder compliance, continence and quality of life in a randomized, placebo-controlled, double-blind study in patients with incontinence due to neurogenic detrusor overactivity. As this group of patients often have severe symptoms, oral tolterodine was allowed as rescue medication and the amount of tolterodine consumed was our primary endpoint.


METHODS
A total of 31 patients with urinary leakage due to spinal cord injury, myelomeningocele, trauma at birth, multiple sclerosis and myelitis of another cause were randomized to intravesical injections of either 500 U of BTX-A or placebo. Intake of tolterodine and episodes of urinary leakage were registered. Cystometry was performed after 6, 12 and 26 weeks and quality of life was assessed.


RESULTS
Patients in the BTX-A group had a significantly lower intake of tolterodine throughout the study compared to those in the placebo group (p=0.003). Cystometric capacity was significantly higher at 6 (p<0.001) and 12 weeks (p=0.026) and maximum detrusor pressure and frequency of urinary leakage were significantly (p<0.01) lower during follow-up in the BTX-A group compared to the placebo group. In addition, many quality-of-life parameters were significantly improved in the BTX-A group compared to the placebo group.


CONCLUSIONS
Intravesical injection of 500 U of BTX-A in patients with neurogenic detrusor instability was shown to be an effective treatment which reduced use of oral medication, high detrusor pressure and frequency of urinary leakage during the overall study period of 26 weeks. Quality of life was also significantly improved.
Ehren
Ingrid
I
Department of Urology, Karolinska University Hospital, S-171 76 Stockholm, Sweden. ingrid.ehren@karolinska.se
Volz
Daniela
D
Farrelly
Elisabeth
E
Berglund
Lena
L
Brundin
Lou
L
Hultling
Claes
C
Lafolie
Pierre
P
D000284:Administration, Oral; D001559:Benzhydryl Compounds / Q000008:administration & dosage; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D003408:Cresols / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000008:administration & dosage; D010665:Phenylpropanolamine / Q000008:administration & dosage; D011788:Quality of Life; D000068737:Tolterodine Tartrate; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; D019274:Botulinum Toxins, Type A