Refractory Urge Incontinence and Botox Injections
Overview
- Phase
- Phase 3
- Intervention
- Botulinum Toxin A, bladder detrusor muscle injection
- Conditions
- Urinary Incontinence
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Enrollment
- 87
- Locations
- 8
- Primary Endpoint
- Time to recurrence of detrusor overactivity incontinence symptoms
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
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 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.
Investigators
Eligibility 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
Arms & Interventions
Botox A
up to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks
Intervention: Botulinum Toxin A, bladder detrusor muscle injection
Placebo
up to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks
Intervention: Vehicle saline as placebo
Outcomes
Primary Outcomes
Time to recurrence of detrusor overactivity incontinence symptoms
Time Frame: 6 months
To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.
Secondary Outcomes
- Change in incontinence episode frequency by bladder diary(At 12 mos after first injection., but no less than 1 mo after second injection)
- Incontinence-related and health-related quality of life(At 12 mos after first injection, but no less than 1 mo after second injection.)
- Voiding dysfunction requiring catheterization(throughout 12-month study)