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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345332
• Other study ID #: 12299
• Status: Completed
• Phase: N/A
• First received: June 27, 2006
• Last updated: August 2, 2011
• Start date: October 2005
• Est. completion date: May 2011

Study information

• Verified date: September 2010
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• Female subjects 21-90 years of age

• subjects has urinary incontinence on 3 day blader diary

• subject has severe incontinence

• urine dipstick or urine colture 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, cyctitis or other correctable etiology for UUI

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• Botox
Injected
• Placebo
Injected

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California at Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder diary, number of daily incontinence episodes		Monthly	No
Secondary	Number of pads used, quality-of-life questionnaires		Monthly	No