Urinary incontinence is a prevalent condition that markedly impacts quality of life and
disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of
urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence
(OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB
symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the
use of anticholinergic medications. These treatment modalities may not result in total
continence and often drug therapy is discontinued because of lack of efficacy, side effects
and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle
exercises require consistent, active intervention by the patient which is often not
sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to
determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more
effective than a standardized regimen of oral anticholinergics in reducing urge urinary
incontinence. 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.
Phase:
Phase 3
Details
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Office of Research on Women's Health (ORWH)
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A Cholinergic Antagonists incobotulinumtoxinA onabotulinumtoxinA Solifenacin Succinate Trospium chloride