A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence

University of Rochester3 sites in 1 country31 target enrollmentOctober 2005

ConditionsUrinary Incontinence

InterventionsPlacebo Botox

DrugsBotox Placebo

Overview

Phase: Not Applicable
Intervention: Placebo
Conditions: Urinary Incontinence
Sponsor: University of Rochester
Enrollment: 31
Locations: 3
Primary Endpoint: Incontinent Episodes Per Day
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Detailed Description

A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

May 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Rochester

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female subjects 21-90 years of age
•subjects has urinary incontinence on 3 day bladder diary
•subject has severe incontinence
•urine dipstick or urine culture negative for urinary tract infection
•cystometrogram without stress urinary leakage
•must have failed at least one anti-cholinergic medication
•negative urine pregnancy test on day of administration of study medication

Exclusion Criteria

•history of carcinoma of the bladder
•presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance
•gross fecal incontinence
•known allergy to sulfa or ciprofloxacin or to lidocaine
•any medical condition that may put the subject at increased risk with exposure to Botox
•females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential
•known allergy to any of the components in the study medication
•prior documented resistance to Botox
•evidence of recent alcohol or drug abuse
•concurrent participation in another investigational drug or device study within 30 days

Arms & Interventions

1

Placebo

Intervention: Placebo

2

Botox

Intervention: Botox

Outcomes

Primary Outcomes

Incontinent Episodes Per Day

Time Frame: week 13

The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.