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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Regina Qu'Appelle Health Region.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier:
NCT01226706
First received: October 18, 2010
Last updated: October 20, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Urinary Urge Incontinence
Non-neurogenic
Drug: botulinum toxin Type A
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Botulinum Toxin A Intradetrusor Injections for the Treatment of Non-neurogenic Urinary Urge Incontinence- A Randomized Double-Blind Control Trial

Resource links provided by NLM:


Further study details as provided by Regina Qu'Appelle Health Region:

Primary Outcome Measures:
  • Maximum capacity at cystoscopy (MCC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra.

    Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate.



Secondary Outcome Measures:
  • Incontinence Episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incontinence- involuntary leakage of urine

  • Number of daytime and night time voids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of daily and nightly urination

  • Patient Perception of Bladder Condition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder

  • Incontinence Impact Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

  • Urogenital Distress Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

  • Indevus Urgency Severity Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder

  • Subjective benefit assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Self assessed description of how well they believed the Botulinum Toxin type A was working, ranging from no change to dry/complete response

  • Adverse effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Documented adverse effects to Botulinum Toxin type A

  • Urinary Tract Infections [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Documented urinary track infections

  • Need for self-catheterization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 24-hour pad test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measures a pad before and after wear to get an indication of urine lost


Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo injected into the detrusor at Day 1,
Drug: Placebo
Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.
Experimental: Botulinum toxin Type A
Botulinum toxin Type A 100U injected into the detrusor at Day 1
Drug: botulinum toxin Type A
Botulinum toxin Type A 100U injected into the detrusor at Day 1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226706

Locations
Canada, Saskatchewan
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Sponsors and Collaborators
Regina Qu'Appelle Health Region
Investigators
Principal Investigator: Corrine Jabs, MD Regina Qu'Appelle Health Region
  More Information

Publications:

Responsible Party: Dr. Corrine Jabs, Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier: NCT01226706     History of Changes
Other Study ID Numbers: REB-08-04, 120486
Study First Received: October 18, 2010
Last Updated: October 20, 2010
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Regina Qu'Appelle Health Region:
Urinary incontinence, urge
detrusor hyperreflexia
detrusor instability
non-neurogenic
Female Urogenital Diseases and Pregnancy Complications
Female Urogenital Diseases
Urologic Diseases
Urination Disorders
Urinary Incontinence

Additional relevant MeSH terms:
Urinary Incontinence, Urge
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014