Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinencePublished on June 30, 2011
Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinence: a randomized, double-blind trial. This is the first-ever North American double-blind placebo-controlled trial of BOTOX® injection into the bladder for neurogenic bladder conditions.
Purpose: To determine the efficacy of the botulinum toxin type-A (onabotulinumtoxinA) in neurogenic detrusor overactivity (NDO) secondary to spinal cord injury (SCI) or multiple sclerosis (MS).
Materials and Methods: In a prospective, double-blind, multicenter study, 57 subjects aged 18–75 years with NDO, and urinary incontinence (UI; ≥1 occurrence/day) despite current antimuscarinic treatment, secondary to SCI or MS, were randomized to receive onabotulinumtoxinA 300U (n=28) or placebo (n=29) via cystoscopic injection at 30 intra-detrusor sites, sparing the trigone. Subjects were offered open-label onabotulinumtoxinA 300U at Week 36 and followed-up for a further six months; 25 subjects from the onabotulinumtoxinA group and 24 from the placebo group elected to receive open-label treatment (one in the onabotulinumtoxinA group discontinued prior to treatment). Primary efficacy parameter was daily UI frequency (on 3-day voiding diary) at Week 6. Secondary parameters included changes in urodynamics and quality of life (QOL) questionnaires (International Consultation on Incontinence Questionnaire and Urinary Incontinence QOL Scale) at Week 6. Diary and QOL evaluations were also performed after open-label treatment.
Results: Mean daily frequency of UI episodes was significantly lower with onabotulinumtoxinA versus placebo at Week 6 (1.31 vs 4.76, P<0.0001), and Weeks 24 and 36. Improvements in urodynamic and QOL parameters with onabotulinumtoxinA versus placebo were evident at Week 6 and persisted to Week 24–36. The most common adverse event in both groups was urinary tract infection.
Conclusions: In adults with antimuscarinic-refractory NDO and UI, onabotulinumtoxinA is well tolerated and provides clinically significant improvements for up to nine months.
Herschorn S, Gajewski J, Ethans K, Corcos J, Carlson K, Bailly G, Bard R, Valiquette L, Baverstock R, Carr L, Radomski S.
Journal of Urology 2011 Jun;185(6):2229-35.