Trials / Terminated
TerminatedNCT00373789
Refractory Urge Incontinence and Botox Injections
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Botulinum Toxin A, bladder detrusor muscle injection | 200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices. |
| DRUG | Vehicle saline as placebo | A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices |
Timeline
- Start date
- 2006-06-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2006-09-08
- Last updated
- 2011-01-11
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00373789. Inclusion in this directory is not an endorsement.