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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226706
First Posted: October 22, 2010
Last Update Posted: July 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corrine Jabs, Regina Qu'Appelle Health Region
  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 Drug: Botulinum Toxins, Type A Drug: Placebos

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Corrine Jabs, Regina Qu'Appelle Health Region:

Primary Outcome Measures:
  • Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up [ Time Frame: Baseline to 6 months ]

    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:
  • Change in Incontinence Episodes Between Baseline and 6 Week Follow-up [ Time Frame: Baseline to 6 weeks ]
    Incontinence- involuntary leakage of urine

  • Change in Incontinence Episodes Between Baseline and 3 Month Follow-up [ Time Frame: Baseline to 3 month ]
    Incontinence- involuntary leakage of urine

  • Change in Incontinence Episodes Between Baseline and 6 Month Follow-up [ Time Frame: Baseline to 6 month ]
    Incontinence- involuntary leakage of urine

  • Change in Incontinence Episodes Between Baseline and 9 Month Follow-up [ Time Frame: Baseline to 9 months ]
    Incontinence- involuntary leakage of urine

  • Change in Incontinence Episodes Between Baseline and 12 Month Follow-up [ Time Frame: Baseline and 12 months ]
    Incontinence- involuntary leakage of urine

  • Change in Incontinence Episodes Between Baseline and 24 Months Follow-up [ Time Frame: Baseline and 24 months ]
    Incontinence- involuntary leakage of urine

  • Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up [ Time Frame: Baseline to 6 weeks ]
    Frequency of daily urination

  • Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up [ Time Frame: Baseline to 3 month ]
    Frequency of daily urination

  • Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up [ Time Frame: Baseline to 6 months ]
    Frequency of daily urination

  • Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up [ Time Frame: Baseline to 9 months ]
    Frequency of daily urination

  • Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up [ Time Frame: Baseline to 12 months ]
    Frequency of daily urination

  • Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up [ Time Frame: Baseline to 24 months ]
    Frequency of daily urination

  • Change in Number of Night Voids Between Baseline and 6 Week Follow-up [ Time Frame: Baseline to 6 weeks ]
    Frequency of night voiding

  • Change in Number of Night Voids Between Baseline and 3 Month Follow-up [ Time Frame: Baseline to 3 months ]
    Frequency of night voiding

  • Change in Number of Night Voids Between Baseline and 6 Month Follow-up [ Time Frame: Baseline to 6 months ]
    Frequency of night voiding

  • Change in Number of Night Voids Between Baseline and 9 Month Follow-up [ Time Frame: Baseline and 9 months ]
    Frequency of night voiding

  • Change in Number of Night Voids Between Baseline and 12 Month Follow-up [ Time Frame: Baseline to 12 months ]
    Frequency of night voiding

  • Change in Number of Night Voids Between Baseline and 24 Months Follow-up [ Time Frame: Baseline and 24 months ]
    Frequency of night voiding

  • Subjective Benefit Assessment at 6 Weeks [ Time Frame: Baseline to 6 weeks ]

    Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:

    1. dry (complete response),
    2. improvement (> 50% reduction in incontinence),
    3. partial response (≤ 50% reduction in incontinence),
    4. no response to treatment.

  • Subjective Benefit Assessment at 3 Months [ Time Frame: Baseline to 3 months ]

    Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:

    1. dry (complete response),
    2. improvement (> 50% reduction in incontinence),
    3. partial response (≤ 50% reduction in incontinence),
    4. no response to treatment.

  • Subjective Benefit Assessment at 6 Months [ Time Frame: Baseline to 6 months ]

    Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients' subjective assessment of the treatment's efficacy was obtained verbally using a four-point rating scale. Rating options were:

    1. dry (complete response),
    2. improvement (> 50% reduction in incontinence),
    3. partial response (≤ 50% reduction in incontinence),
    4. no response to treatment.

  • Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up [ Time Frame: Baseline to 6 weeks ]

    Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

    Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.


  • Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up [ Time Frame: Baseline to 3 months ]

    Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

    Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.


  • Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up [ Time Frame: Baseline to 6 months ]

    Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

    Incontinences Impact Questionnaire - 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients' life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.


  • Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up [ Time Frame: Baseline to 6 weeks ]

    Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

    Urogenital Distress Inventory - 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.


  • Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up [ Time Frame: Baseline to 3 months ]

    Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

    The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.


  • Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up [ Time Frame: Baseline to 6 months ]

    Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

    The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.


  • Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks [ Time Frame: Baseline to 6 weeks ]

    Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.

    Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems.


  • Change in Patient Perception of Bladder Condition From Baseline to 3 Months [ Time Frame: Baseline to 3 months ]

    Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.

    Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems.


  • Change in Patient Perception of Bladder Condition From Baseline to 6 Months [ Time Frame: Baseline to 6 months ]

    Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.

    Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all", 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 "many severe problems". A higher score indicates a more negative impression of current bladder problems.


  • Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks [ Time Frame: Baseline to 6 weeks ]

    A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.

    Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges.


  • Change in Indevus Urgency Severity Scale From Baseline to 3 Months [ Time Frame: Baseline to 3 months ]

    A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.

    Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges.


  • Change in Indevus Urgency Severity Scale From Baseline to 6 Months [ Time Frame: Baseline to 6 months ]

    A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.

    Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient's urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges.


  • 24 Hour Pad Weight (gm) at 3 Months [ Time Frame: 3 months ]
    weight of pad (in gm) worn for 24 hours to detect urine loss

  • 24 Hour Pad Weight (gm) at 9 Months [ Time Frame: 9 months ]
    weight of pad (in gm) worn for 24 hours to detect urine loss

  • Frequency of Urinary Tract Infections From Baseline to 6 Months [ Time Frame: Baseline to 6 months ]
    Frequency of urinary tract infections from baseline to 6 month-follow-up

  • Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up [ Time Frame: Baseline to 6 months ]
    Frequency of participants needing self-catheterization from baseline to 6 month follow-up.

  • Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months [ Time Frame: Baseline to 6 months ]
    Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up


Enrollment: 21
Study Start Date: June 2008
Study Completion Date: October 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebos
Placebo injected into the detrusor at Day 1,
Drug: Placebos
Placebos 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 Toxins, Type A
Botulinum Toxins, Type A 100U injected into the detrusor at Day 1
Drug: Botulinum Toxins, Type A
Botulinum Toxins, Type A 100U injected into the detrusor at Day 1

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Corrine Jabs, Department Head Obstetrics & Gynecology, Regina Qu'Appelle Health Region
ClinicalTrials.gov Identifier: NCT01226706     History of Changes
Other Study ID Numbers: REB-08-04
120486 ( Registry Identifier: Health Canada )
First Submitted: October 18, 2010
First Posted: October 22, 2010
Results First Submitted: August 4, 2015
Results First Posted: July 3, 2017
Last Update Posted: July 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Corrine Jabs, 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
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents