Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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, pelvic floor exercises, anticholinergic medication, and less commonly, sacral neuromodulation. Unfortunately anticholinergic therapy is only moderately effective.

Botulinum toxin A (BTA or Botox©) may be a useful treatment in patients that do not respond to standard therapy. Botulinum toxin A has been used in other studies to improve symptoms in neurogenic urinary incontinence, and a variety of lower urinary tract disorders. BTA has been used in other studies to improve the symptoms in urinary incontinence, migraines, spinal cord injuries and a variety of lower urinary tract disorders. However, the treatment of non-neurogenic urinary urge incontinence has not been examined in a well-controlled study.

The primary purpose of this study is to determine the efficacy of botulinum toxin A (BTA) in the treatment of non-neurogenic urinary urge incontinence (UUI). The secondary objectives are to examine the side effects associated with BTA treatment and the impact this treatment has on patients' quality of life.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regina Qu'Appelle Health Region; Saskatchewan Health Authority - Regina Area
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)