Outcome of a Randomized, Double-Blind, Placebo Controlled Trial of Botulinum A Toxin for Refractory Overactive Bladder

Abstract

Purpose-We determined the effectiveness of cystoscopic administration of botulinum-A toxin compared to placebo for the treatment of urinary incontinence in subjects with idiopathic overactive bladder.Materials and Methods-Subjects were recruited from the Division of Urogynecology at the University of Rochester. Inclusion criteria were overactive bladder refractory to anticholinergic medications, multiple daily incontinence episodes and a 24hour pad weight of 100 gm or greater. Subjects with low leak point pressures, increased post-void residual volume or neurological etiologies were excluded from study. Subjects were randomized to placebo or to 1 of 2 doses of botulinum-A toxin. The detrusor was injected at 8 to 10 sites above the trigone. Evaluations were performed at baseline, and at 3 and 6 weeks after injection, and included bladder diaries, pad weights, quality of life questionnaires and urodynamic studies.Results-A total of 22 subjects participated in stage 1 of this 2-stage study. We report on the outcomes of stage 1 of this study. Because stage 2 is still ongoing and investigators remain blind to the doses of botulinum-A toxin, the 2 botulinum-A toxin groups were combined for this report. There were no differences in mean baseline measurements between the 2 groups. Statistically significant improvements in daily incontinence episodes, pads changed per day and quality of life questionnaires were seen in the botulinum-A toxin group with no changes in the placebo group. No change in nocturia, daily voiding frequency, peak flow or detrusor pressure was seen in either group. Of 15 subjects 4 (26%) receiving botulinum-A toxin had a post-void residual volume of 200 cc or greater and 1 subject required intermittent catheterization. Four subjects experienced a urinary tract infection, 2 (13%) in the botulinum-A toxin group and 2 (28%) in the placebo group (not significant).Conclusions-Botulinum-A toxin can significantly reduce urge urinary incontinence due to overactive bladder at 6 weeks. However, there is a risk of urinary retention requiring selfcatheterization. The effects of botulinum-A toxin on striated muscle are well documented in the neurology and plastic surgery literature. [3][4][5][6][7][8] Several studies including a recent randomized, placebo controlled trial have shown that BTX is effective for neurogenic detrusor overactivity. 9-11 Recent uncontrolled case series have shown significant reductions in incontinence and improvement in urodynamic parameters in subjects with idiopathic OAB. [12][13][14][15][16] We describe the out comes of a randomized, double-blind, placebo controlled trial of BTX for the treatment of severe OAB. Keywords MATERIALS AND METHODSThis study was performed at the University of Rochester, Rochester, New York. The institutional review board approved this protocol and the trial was registered with the National Institutes of Health clinical trials website before study initiation. This study includes 2 stages, with stage 1 a 6-week randomized, placebo controlled trial and...

Botulinum A Toxin Intravesical Injections in the Treatment of Refractory Overactive Bladder in Patients with Parkinson's Disease

“…Worth of noting, incomplete voiding symptoms were unrelated to the BoNT/A dosage used. Also patients with multiple sclerosis treated with 100 Units and patients with idiopathic overactive bladder treated with 200 and 300 units of BoNT/A showed an increase in post-void residual volume (Flynn et al, 2009;Mehnert et al, 2010;Sahai et al, 2009). Our results on post-void residual volume are in contrast with those reported by Kulaksizoglu and Parman (Kulaksizoglu & Parman, 2010) who treated parkinsonian patients with Dysport 500 Units.…”

Botulinum Toxin-A Injections for Idiopathic Overactive Bladder: A Systematic Review and Meta-Analysis

“…Seven trials compared botulinum toxin-A with placebo [6,7,8,9,10,11,14,16,18,19,20]. They included 782 patients; 23 patients were lost to follow-up.…”

“…The percentage of patients with >75% improvement in urgency and urge urinary incontinence episodes at month 3 was greater in all botulinum toxin-A groups in Denys et al's study (p = 0.03) [11]. Compared with baseline at 6 weeks (p = 0.02), in Flynn et al's study [19], nocturia was reduced in the whole botulinum toxin-A group, however, there was no difference between botulinum toxin-A and placebo in nocturia reduction (p = 0.91). According to the measure of the Patient Global Impression of Improvement scale, Brubaker et al [18] found that 60% of patients receiving 200 U botulinum toxin-A had a clinical response at month 2.…”

Onabotulinumtoxina Intravesical Treatment in Patients Affected by Overactive Bladder Syndrome: Best Practice in Real-Life Management

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