Study:
Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
Rationale:
n/a
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Urge Urinary Incontinence
Overactive Bladder |
Drug: Botulinum toxin A (Botox A®)
Drug: Solifenacin 5mg
Drug: Solifenacin 10mg
Drug: Trospium chloride |
Phase 3 |
Verified by
Susan Meikle, MD MSPH
January, 2013
Sponsored by: Susan Meikle, MD MSPH
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov identifier: NCT01166438
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Anthony Visco, MD., Study Chair