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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
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Normal saline (Placebo); botulinum toxin Type A (200U)
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
botulinum toxin Type A (200U)
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
  • 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

Experimental

Other

Arm Label

1

2

3

4

Arm Description

botulinum toxin Type A (50U); botulinum toxin Type A (200U)

botulinum toxin Type A (100U); botulinum toxin Type A (200U)

botulinum toxin Type A (200U)

placebo; botulinum toxin Type A (200U)

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.

Full Information

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

Unique Protocol Identification Number
NCT00575016
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
Terminated
Why Stopped
The study was terminated early due to enrollment challenges.
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
July 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 explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
Arm Title
2
Arm Type
Experimental
Arm Description
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
Arm Title
3
Arm Type
Experimental
Arm Description
botulinum toxin Type A (200U)
Arm Title
4
Arm Type
Other
Arm Description
placebo; botulinum toxin Type A (200U)
Intervention Type
Biological
Intervention Name(s)
Normal saline (Placebo); botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Intervention Type
Biological
Intervention Name(s)
botulinum toxin Type A (200U)
Other Intervention Name(s)
BOTOX®
Intervention Description
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the 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 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

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 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
Cairo
Country
Egypt
City
Thessaloniki
Country
Greece
City
Ahmadabad
Country
India
City
Beirut
Country
Lebanon
City
Belgrade
Country
Serbia
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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

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