A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Drug: Placebo; Drug: Botox

• Registration Number: NCT00345332
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2016-04-04
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-07
• Results First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	Botox	Botox

Primary Outcome Measures

Name	Time	Method
Incontinent Episodes Per Day	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.

Secondary Outcome Measures

Name	Time	Method
Number of Incontinence Pads Used Per Day	week 13	The number of incontinence pads used per day per day was recorded by each participant in a diary.

Trial Locations

Locations (3)

University of California at Davis; 🇺🇸 Sacramento, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States