Efficacy of Botulinum Toxin-A for Treating Idiopathic Detrusor Overactivity: Results From a Single Center, Randomized, Double-Blind, Placebo Controlled Trial
We evaluated the use of botulinum toxin-A in treating patients with idiopathic detrusor overactivity refractory to anticholinergics.
Materials and Methods:
This double-blind, placebo controlled trial randomized participants to intradetrusor injections of 200 U botulinum toxin-A (16 patients) or placebo (18 patients). The primary outcome measure was change in maximum cystometric capacity. Secondary outcome measures included changes in overactive bladder symptoms, post-void residual, maximum detrusor pressure during filling cystometry and reflex detrusor volume. Quality of life was assessed using the Incontinence Impact Questionnaire short form 7 and Urogenital Distress Inventory short form 6. Followup occurred at 4 and 12 weeks after injection, at which point the study was unblinded. Further followup in the botulinum toxin-A group occurred at 24 weeks.
Significant increases in maximum cystometric capacity were observed at 4 weeks (difference 144.69 ml, 95% CI 100.95 to 215.75, p <0.0001) and 12 weeks (difference 95.71 ml, 95% CI 47.47 to 172.45, p = 0.001) in patients treated with botulinum toxin-A compared to placebo. Botulinum toxin-A reduced frequency (p <0.001, p = 0.003) and urgency urinary incontinence (p = 0.03, p = 0.008) episodes at 4 and 12 weeks, respectively. Urgency was reduced at 4 weeks (p = 0.005) in the botulinum toxin-A group. In patients receiving botulinum toxin-A, post-void residual increased at 4 weeks (p = 0.024) but became insignificant by 12 weeks (p = 0.406). Of these patients 6 required intermittent self-catheterization. Significant improvements in quality of life were observed following botulinum toxin-A. The extension study suggests that the beneficial effects of botulinum toxin-A are maintained for at least 24 weeks.
Botulinum toxin-A at 200 U is safe and effective for idiopathic detrusor overactivity and the beneficial effects persist for at least 24 weeks.
- 1 : The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn2002; 21: 167. Google Scholar
- 2 : Botulinum toxin for the treatment of lower urinary tract symptoms: a review. Neurourol Urodyn2005; 24: 2. Google Scholar
- 3 : European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol2004; 45: 510. Google Scholar
- 4 : Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs?: Preliminary results. J Urol2000; 164: 692. Link, Google Scholar
- 5 : Botulinum toxin type A is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. J Urol2005; 174: 196. Link, Google Scholar
- 6 : A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. J Urol2005; 174: 984. Link, Google Scholar
- 7 : The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol2004; 172: 2316. Link, Google Scholar
- 8 : Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Urology2005; 66: 94. Google Scholar
- 9 : A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int2005; 96: 848. Google Scholar
- 10 : Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. J Urol2006; 176: 177. Link, Google Scholar
- 11 : Botulinum-A toxin detrusor and sphincter injection in treatment of overactive bladder syndrome: objective outcome and patient satisfaction. Eur Urol2005; 48: 984. Google Scholar
- 12 : Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity?. Neurourol Urodyn2005; 24: 231. Google Scholar
- 13 : Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn2002; 21: 261. Google Scholar
- 14 : Potentiation of Clostridium botulinum toxin aminoglycoside antibiotics: clinical and laboratory observations. Pediatrics1981; 68: 50. Google Scholar
- 15 : A minimally invasive technique for outpatient local anaesthetic administration of intradetrusor botulinum toxin in intractable detrusor overactivity. BJU Int2003; 92: 325. Google Scholar
- 16 : Techniques for the intradetrusor administration of botulinum toxin. BJU Int2006; 97: 675. Google Scholar
- 17 : Quality of life changes in patients with neurogenic versus idiopathic detrusor overactivity after intradetrusor injections of botulinum neurotoxin type A and correlations with lower urinary tract symptoms and urodynamic changes. Eur Urol2006; 49: 528. Google Scholar
- 18 : Cost-consequence analysis evaluating the use of botulinum neurotoxin-A in patients with detrusor overactivity based on clinical outcomes observed at a single UK centre. Eur Urol2006; 49: 519. Google Scholar
- 19 : Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. J Urol2005; 174: 1873. Link, Google Scholar
- 20 : Proposed mechanism for the efficacy of injected botulinum toxin in the treatment of human detrusor overactivity. Eur Urol2006; 49: 644. Google Scholar
Guy’s, King’s and St. Thomas’s Hospitals, London, United Kingdom