Ghei, M.; (2008) Effects of Botulinum Toxin B on refractory detrusor overactivity: a randomised, double-blind, placebo controlled, cross over trial. Doctoral thesis , University of London.

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Abstract

INTRODUCTION: Open, observational studies of intradetrusor injections of Botulinum toxin for detrusor overactivity have reported beneficial effects. This thesis reports the testing of the efficacy and safety of Botulinum toxin B (BTX-B) for treatment of the overactive bladder in a randomised, double-blind, placebo controlled cross-over trial.;METHOD: 20 patients, aged 18-80 years, with detrusor overactivity, and incompletely responsive to oral antimuscarinic agents, participated. They were injected with either placebo (20 mis normal saline) or botulinum toxin B (5000 IU diluted up to 20 mis) into the detrusor in a day case setting. After six weeks, the treatments were crossed over without washout. The primary outcome was the paired difference in change in the average voided volumes. Paired differences urinary frequency, incontinence episodes and in the quality of life (QOL), measured by the King's Health Questionnaire (KHQ), were the secondary outcome measures. On the occasion of each injection two biopsies were taken from the detrusor. These were processed and scrutinised for evidence of inflammatory responses to the injection.;RESULTS: The Wilcoxon Signed Ranks Test was used to test the paired difference in change between treatment phases. Statistically significant paired differences in the change in average voided volume, urinary frequency and episodes of incontinence between active treatment and placebo (Av Void Vol: 95% CI diff 16, 122 Z = -2.5 p=0.012 / Weekly Freq: 95% CI -21, -1 Z = -2.1, p=0.033 / Weekly incont: 95% CI -26, -7 Z=-3.3 p=0.001) along with significant paired differences in five domains of the KHQ were observed.;CONCLUSIONS: This double-blind, placebo-controlled, cross-over study provides evidence of efficacy of Botulinum Toxin B in the treatment of the overactive bladder. Autonomic side effects were observed in four of the patients. The short duration of action will presumably limit the use to patients who have experienced tachyphylaxis with (Botulinum toxin A) BTX-A.

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