This study is a 6-month double-blind randomized trial comparing intra-detrusor botulinum toxin A (Botox A®) and anticholinergic therapy in women without neurologic disease with urge incontinence. All subjects will receive active drug and all subjects will receive placebo (see below). Subjects will be followed up to an additional six months off study drug to determine duration of treatment effect.
The primary aim is to compare the change in urge incontinence episodes over 6 months between women receiving a single intra-detrusor injection of 100 unit of botulinum toxin A (Botox A®) plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of saline plus daily anticholinergic therapy. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.
The secondary aims are:
1) To compare efficacy of both treatments arms in reducing urgency and urge incontinence (occurrence and bother).
2) To assess duration of effect (time with adequate control of urinary leakage) of each treatment arm (single injection of 100U botulinum toxin A or 6 months of anticholinergic therapy)
3) To compare the change from baseline in pelvic floor-specific, sexual and overall quality of life measures and treatment satisfaction between botulinum toxin A and anticholinergic medication
4) To compare safety and tolerability (urinary retention requiring catheterization, incomplete bladder emptying, dry mouth, dry eyes, constipation) between botulinum toxin A and anticholinergic medication
5) To compare compliance with placebo versus active pills
6) To compare cost-effectiveness between botulinum toxin A and anticholinergics management of urge incontinence
7) To describe outcomes (symptom control, urinary tract infections) using a standardized threshold and regimen for instituting clean intermittent self-catheterization
8) To describe clinical and urodynamic parameters (measured at baseline) that are associated with effectiveness and side effects including new onset voiding dysfunction and partial urinary retention in both treatment groups
9) To describe the proportion of subjects who have adequate symptom control with the active standardized anticholinergic regimen