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Safety 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
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 or 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 the 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

First Posted
April 13, 2007
Last Updated
September 17, 2015
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00461292
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
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 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
275 (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 injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A (300U)
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
Intervention Type
Other
Intervention Name(s)
Normal saline (Placebo); botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor
Intervention Type
Other
Intervention Name(s)
Normal saline (Placebo); botulinum toxin Type A (300U)
Other Intervention Name(s)
BOTOX®
Intervention Description
Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
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 the 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 or 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
Middlebury
State/Province
Connecticut
Country
United States
City
Rio de Janeiro
Country
Brazil
City
Victoria
State/Province
British Columbia
Country
Canada
City
Salouel
Country
France
City
Milan
Country
Italy
City
Amsterdam
Country
Netherlands
City
Porto
Country
Portugal
City
Singapore
Country
Singapore
City
Pretoria
Country
South Africa
City
Tenerife
Country
Spain
City
Hualien
Country
Taiwan
City
Scunthorpe
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
22965657
Citation
Sussman 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.
Results Reference
derived
PubMed Identifier
21798658
Citation
Cruz 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.
Results Reference
derived

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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

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