Back to resultsSafety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
botulinum toxin Type A (200U)
botulinum toxin Type A (300U)
Normal Saline (Placebo); botulinum toxin Type A (200U)
Normal Saline (Placebo); botulinum toxin Type A (300U)
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 Exclusion Criteria: History of evidence of pelvic or urologic abnormality Previous or current diagnosis of bladder or prostate cancer 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
1
2
3
4
Arm Description
botulinum toxin Type A (200U)
botulinum toxin Type A (300U)
placebo; botulinum toxin Type A (200U)
placebo; botulinum toxin Type A (300U)
Outcomes
Primary Outcome Measures
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Secondary Outcome Measures
Change From Baseline in Maximum Cystometric Capacity (MCC)
Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
Change From Baseline in Maximum Detrusor Pressure (MDP)
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311376
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
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
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
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
botulinum toxin Type A (200U)
Arm Title
2
Arm Type
Experimental
Arm Description
botulinum toxin Type A (300U)
Arm Title
3
Arm Type
Other
Arm Description
placebo; botulinum toxin Type A (200U)
Arm Title
4
Arm Type
Other
Arm Description
placebo; botulinum toxin Type A (300U)
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A (300U)
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval
Intervention Type
Other
Intervention Name(s)
Normal Saline (Placebo); botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
Intervention Type
Other
Intervention Name(s)
Normal Saline (Placebo); botulinum toxin Type A (300U)
Other Intervention Name(s)
BOTOX®
Intervention Description
Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval
Primary Outcome Measure Information:
Title
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Description
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Maximum Cystometric Capacity (MCC)
Description
Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Maximum Detrusor Pressure (MDP)
Description
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
Description
Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). A positive change from baseline represents an improvement
Time Frame
Baseline, Week 6
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
Exclusion Criteria:
History of evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer
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
Royal Oak
State/Province
Michigan
Country
United States
City
Randwick
State/Province
New South Wales
Country
Australia
City
Innsbruck
Country
Austria
City
Gent
Country
Belgium
City
Sherbrooke
Country
Canada
City
Ostrava
Country
Czech Republic
City
Garches
Country
France
City
Halle (Saale)
Country
Germany
City
Christchurch
Country
New Zealand
City
Wroclaw
Country
Poland
City
Moscow
Country
Russian Federation
City
Martin
Country
Slovakia
City
Lviv
Country
Ukraine
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25288099
Citation
Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.
Results Reference
derived
PubMed Identifier
23892704
Citation
Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26.
Results Reference
derived
PubMed Identifier
22503020
Citation
Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.
Results Reference
derived
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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