GYNAECOLOGYEfficacy of Botulinum Toxin A Intradetrusor Injections for Non-neurogenic Urinary Urge Incontinence: A Randomized Double-Blind Controlled Trial
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INTRODUCTION
Overactive bladder is a condition characterized by urgency with or without urinary urge incontinence.1 It causes individuals to feel an urgent need to urinate because of involuntary bladder contractions and is a common quality-of-life disorder that becomes more prevalent with age.1 Standard treatment for urinary urge incontinence includes behaviour modification, pelvic floor exercises, anticholinergic medication, and, less commonly, sacral neuromodulation.2 Unfortunately, anticholinergic
METHODS
We conducted a single-institution, six-month randomized, double-blind controlled trial of botulinum toxin in patients with idiopathic urge incontinence recruited from the practice of a single urogynaecologist (C.J.). Subjects in the placebo group were offered botulinum toxin after the six-month follow-up visit.
Women over 18 years of age with a confirmed diagnosis of idiopathic urge incontinence refractory to anticholinergic treatment were considered eligible for inclusion. The diagnosis was
RESULTS
Eleven participants were randomized to the treatment group (botulinum toxin) and 10 to the control group between February 2008 and September 2009. Recruitment was stopped at 21 subjects because of slow accrual; this was attributed to the introduction of two new anticholinergic medications following initiation of the study. The flow of patients through the study is shown in Figure 1. All subjects received their assigned treatment and no subjects were lost to follow-up. Patient characteristics
DISCUSSION
In this study, based on both objective and subjective endpoints, 100 U of botulinum toxin was somewhat effective at improving urinary urge incontinence symptoms. The treatment group had a significant increase in the primary outcome, maximum bladder capacity at cystoscopy, with a 14% increase from baseline to six months. At three months, 55% of the treatment group had a dry pad test. There was also a significant difference in the groups’ subjective assessment of benefit from treatment, with 55%
CONCLUSION
Intradetrusor injections of 100 U of botulinum toxin A were well tolerated and resulted in improvement in adult women with non-neurogenic urinary urge incontinence resistant to anticholinergic medication. A total injection dose of 100 U appears to be an optimal initial dose and can be repeated after six months. Most participants did not require or want sedation for this procedure, improving the availability of botulinum toxin treatment and reducing wait times. The technique of botulinum toxin
ACKNOWLEDGEMENT
Allergan Inc. (Markham, Ontario) provided an honorarium for a urologist experienced in the use of botulinum toxin to be the first author’s preceptor. Allergan Inc. also provided eight vials of botulinum toxin for the day of training. There was no financial support for this study.
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Competing interests: None declared.