Anticholinergic vs. Botox Comparison Study

Summary

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.

Conditions

• Urge Urinary Incontinence
• Overactive Bladder

Interventions

DRUG

Botulinum toxin A (Botox A®)

A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.

DRUG

Solifenacin 5mg

Oral Solifenacin 5mg once a day for up to 6 months

DRUG

Solifenacin 10mg

Oral Solifenacin 10mg once a day for up to 4 months

DRUG

Trospium chloride

Oral Trospium chloride XR 60mg once a day for up to 2 months

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Pelvic Floor Disorders Network

  lead NETWORK

Principal Investigators

• Anthony Visco, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2012-05-31

Completion

2012-05-31

Countries

• United States

Study Locations