Status:
TERMINATED
Refractory Urge Incontinence and Botox Injections
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Urinary Incontinence
Detrusor Overactivity
Eligibility:
FEMALE
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.
Detailed Description
Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in cen...
Eligibility Criteria
Inclusion
- Adult women
- Detrusor overactivity incontinence confirmed by urodynamic testing
- Symptoms refractory to standard first- and second-line treatments
- 6 or more urge incontinence episodes on 3-day bladder diary
- Normal neurological examination
Exclusion
- Urinary retention
- Allergy to Botox (Botulinum Toxin A)
- Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
- Pregnancy or planning pregnancy within next year
- Neurologic disease with impaired neurotransmission
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00373789
Start Date
June 1 2006
End Date
December 1 2007
Last Update
January 11 2011
Active Locations (8)
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1
University of Alabama
Birmingham, Alabama, United States, 35249
2
USCD Medical Center
La Jolla, California, United States, 92037
3
Kaiser Permanente
San Diego, California, United States, 92120
4
Loyola University
Maywood, Illinois, United States, 60153