Refractory Urge Incontinence and Botox Injections
This study has been terminated.
(higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00373789
First received: September 6, 2006
Last updated: January 9, 2011
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence Detrusor Overactivity Urinary Urgency Urge Urinary Incontinence |
Drug: Botulinum Toxin A, bladder detrusor muscle injection Drug: Vehicle saline as placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Refractory Urge Incontinence and Botox Injections |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Time to recurrence of detrusor overactivity incontinence symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 Outcome Measures:
- Change in incontinence episode frequency by bladder diary [ Time Frame: At 12 mos after first injection., but no less than 1 mo after second injection ] [ Designated as safety issue: No ]based on the 3-day bladder diary completed pre-intervention and at 4 weeks post injection. A successful within-subject outcome will be defined as >75% reduction in the frequency of urge incontinence episodes compared to the baseline frequency.
- Incontinence-related and health-related quality of life [ Time Frame: At 12 mos after first injection, but no less than 1 mo after second injection. ] [ Designated as safety issue: No ]measured by the Urinary Distress Inventory subscale of the PFDI/PFIQ, the PISQ, and SF-36 administered at 4 weeks after the initial injection and either prior to any re-treatment or at the completion of study participation, whichever is earlier.
- Voiding dysfunction requiring catheterization [ Time Frame: throughout 12-month study ] [ Designated as safety issue: Yes ]
| Enrollment: | 87 |
| Study Start Date: | June 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
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.
Other Name: Botox
|
|
Placebo Comparator: 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
|
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
|
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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373789
Locations
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| USCD Medical Center | |
| La Jolla, California, United States, 92037 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92120 | |
| United States, Illinois | |
| Loyola University | |
| Maywood, Illinois, United States, 60153 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| UT Southwestern | |
| Dallas, Texas, United States, 35249 | |
| United States, Utah | |
| Univeristy of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Linda Brubaker, MD | Loyola University |
More Information
Additional Information:
Publications:
| Responsible Party: | Susan Meikle, MD, NICHD |
| ClinicalTrials.gov Identifier: | NCT00373789 History of Changes |
| Other Study ID Numbers: | PFDN 12 |
| Study First Received: | September 6, 2006 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Botulinum Toxin A Urinary Incontinence Detrusor Overactivity |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Botulinum Toxins, Type A Botulinum Toxins |
Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013