Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
1 other identifier
interventional
275
12 countries
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2007
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2007
CompletedFirst Posted
Study publicly available on registry
April 17, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
October 17, 2011
CompletedOctober 2, 2015
September 1, 2015
2.8 years
April 13, 2007
September 9, 2011
September 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline, Week 6
Secondary Outcomes (3)
Change From Baseline in Maximum Cystometric Capacity (MCC)
Baseline, Week 6
Change From Baseline in Maximum Detrusor Pressure (MDP)
Baseline, Week 6
Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
Baseline, Week 6
Study Arms (4)
1
EXPERIMENTALbotulinum toxin Type A (200U)
2
EXPERIMENTALbotulinum toxin Type A (300U)
3
OTHERplacebo; botulinum toxin Type A (200U)
4
OTHERplacebo; botulinum toxin Type A (300U)
Interventions
botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection \> Week 12; injections into detrusor
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection \> 12 weeks; injections into detrusor
Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection \> Week 12; injections into detrusor
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History or evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Urinary tract infection at time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (12)
Unknown Facility
Middlebury, Connecticut, United States
Unknown Facility
Rio de Janeiro, Brazil
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Salouël, France
Unknown Facility
Milan, Italy
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Porto, Portugal
Unknown Facility
Singapore, Singapore
Unknown Facility
Pretoria, South Africa
Unknown Facility
Santa Cruz de Tenerife, Spain
Unknown Facility
Hualien City, Taiwan
Unknown Facility
Scunthorpe, United Kingdom
Related Publications (3)
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.
PMID: 25288099DERIVEDSussman D, Patel V, Del Popolo G, Lam W, Globe D, Pommerville P. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2013 Mar;32(3):242-9. doi: 10.1002/nau.22293. Epub 2012 Sep 10.
PMID: 22965657DERIVEDCruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. doi: 10.1016/j.eururo.2011.07.002. Epub 2011 Jul 13.
PMID: 21798658DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2007
First Posted
April 17, 2007
Study Start
May 1, 2007
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
October 2, 2015
Results First Posted
October 17, 2011
Record last verified: 2015-09