Back to resultsSafety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
botulinum toxin Type A
Normal Saline (Placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
- Inadequate response to anticholinergic medication used to treat overactive bladder.
- Neurological respiratory impairment and abnormal pulmonary function test results
Exclusion Criteria:
- History or evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Symptomatic or untreated urinary tract infection at time of enrollment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Other
Other
Arm Label
botulinum toxin Type A 200U
botulinum toxin Type A 300U
Placebo/botulinum toxin Type A 200U
Placebo/botulinum toxin Type A 300U
Arm Description
Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).
Outcomes
Primary Outcome Measures
Change From Baseline in Forced Vital Capacity (FVC)
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.
Change From Baseline in FEV1/FVC Ratio
The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.
Secondary Outcome Measures
Change From Baseline in the Number of Urinary Incontinence Episodes
The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).
Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)
MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).
Change From Baseline in Maximum Cystometric Capacity (MCC)
MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439140
Brief Title
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
In agreement with FDA the study was terminated based on data available.
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.
Detailed Description
Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin Type A 200U
Arm Type
Experimental
Arm Description
Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Arm Title
botulinum toxin Type A 300U
Arm Type
Experimental
Arm Description
Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
Arm Title
Placebo/botulinum toxin Type A 200U
Arm Type
Other
Arm Description
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
Arm Title
Placebo/botulinum toxin Type A 300U
Arm Type
Other
Arm Description
Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A
Other Intervention Name(s)
BOTOX®, onabotulinumtoxinA
Intervention Description
Botulinum toxin Type A injection into the detrusor.
Intervention Type
Drug
Intervention Name(s)
Normal Saline (Placebo)
Intervention Description
Placebo (Normal Saline) injection into the detrusor.
Primary Outcome Measure Information:
Title
Change From Baseline in Forced Vital Capacity (FVC)
Description
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Description
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.
Time Frame
Baseline, Week 6
Title
Change From Baseline in FEV1/FVC Ratio
Description
The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in the Number of Urinary Incontinence Episodes
Description
The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).
Time Frame
Baseline, Week 6
Title
Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)
Description
MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure [measured in centimeters water (cm H20)] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).
Time Frame
Baseline, Week 6
Title
Change From Baseline in Maximum Cystometric Capacity (MCC)
Description
MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).
Time Frame
Baseline, Week 6
Other Pre-specified Outcome Measures:
Title
Number of Participants With at Least a 15% Decrease From Baseline in FVC
Description
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.
Time Frame
Baseline, Weeks 2, 6 and 12
Title
Number of Participants With at Least a 20% Decrease From Baseline in FVC
Description
Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible at Baseline, Weeks 2, 6 and 12.
Time Frame
Baseline, Weeks 2, 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
Inadequate response to anticholinergic medication used to treat overactive bladder.
Neurological respiratory impairment and abnormal pulmonary function test results
Exclusion Criteria:
History or evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer
Symptomatic or untreated urinary tract infection at time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Herston
State/Province
Queensland
Country
Australia
City
Victoria
State/Province
British Columbia
Country
Canada
City
Chennai
Country
India
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
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