Status:
COMPLETED
Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence
Lead Sponsor:
Saskatchewan Health Authority - Regina Area
Conditions:
Urinary Urge Incontinence
Eligibility:
FEMALE
17-80 years
Phase:
NA
Brief Summary
Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that causes people to feel an "urgent" need to urinate. Standard treatment for UUI includes behavior modification, p...
Detailed Description
Introduction: Non-neurogenic urinary urge incontinence (UUI) is a common quality of life disorder that becomes more prevalent with age. It is described as a condition that causes people to feel an "u...
Eligibility Criteria
Inclusion
- Female subjects, greater than 17 years of age
- Written informed consent has been obtained
- Ability to follow study instructions and likely to complete all required visits
- Written authorization for Use and Release of Health and Research Study Information has been obtained
- Subject meets the following criteria: clinical diagnosis of urinary urge incontinence with resistance to or intolerance of anticholinergic medication
- Anticholinergic medications allowed
- Willingness and ability to use self-catheterization if necessary
Exclusion
- Uncontrolled clinically significant medical condition other than the condition under evaluation
- Known allergy or sensitivity to any of the components in the study medication
- Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study
- Concurrent participation in another investigational drug or device study
- Treatment with botulinum toxin of any serotype for urological condition prior to enrolment in study (if applicable)
- Any medical condition that may put the subject at increased risk with exposure to botulinum toxin A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
- Symptomatic urinary retention or post-void residual of \>200ml
- Anticoagulation therapy within 3 days of injection procedure
- Familial bleeding disorder
- UUI secondary to neurologic disease
- Myasthenia gravis
- Previous bladder pathology (e.g. transitional cell carcinoma)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01226706
Start Date
June 1 2008
End Date
October 1 2012
Last Update
July 3 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5