Refractory Urge Incontinence and Botox Injections
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence; Detrusor Overactivity; Urinary Urgency; Urge Urinary Incontinence
Intervention: Botulinum Toxin A, bladder detrusor muscle injection (Drug); Vehicle saline as placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Anne M Weber, MD, MS, Study Director, Affiliation: National Institute of Child Health and Human Development (NICHD)
Morton B Brown, PhD, Principal Investigator, Affiliation: Data Coordinating Center, University of Michigan
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.
Clinical Details
Official title: Refractory Urge Incontinence and Botox Injections
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Questionnaire time to recurrence of detrusor overactivity incontinence symptoms
Secondary outcome: Change in incontinence episode frequency by bladder diaryIncontinence-related quality of life Health-related quality of life Voiding dysfunction requiring catheterization
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 centers across the US. Study participants will undergo cystoscopy (telescope
look into the bladder) and injection of either Botox A or placebo. If symptoms are not
adequately relieved, subjects participants will receive a second injection that is Botox A.
Participants are interviewed monthly by study personnel to determine symptoms and health
status.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
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 Criteria:
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
Locations and Contacts
University of Alabama, Birmingham, Alabama 35249, United States
USCD Medical Center, La Jolla, California 92037, United States
Kaiser Permanente, San Diego, California 92120, United States
Loyola University, Maywood, Illinois 60153, United States
University of North Carolina, Chapel Hill, North Carolina 27599, United States
Cleveland Clinic, Cleveland, Ohio 44195, United States
UT Southwestern, Dallas, Texas 35249, United States
Univeristy of Utah, Salt Lake City, Utah 84132, United States
Additional Information
Public website for the Pelvic Floor Disorders Network Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network
Starting date: June 2006
Ending date: December 2007
Last updated: June 19, 2007
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