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

Phase 2

Terminated

• Conditions: Overactive Bladder
• Interventions: Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U); Biological: botulinum toxin Type A (200U); Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U); Biological: Normal saline (Placebo); botulinum toxin Type A (200U)

• Registration Number: NCT00575016
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2010-02
• Study Completion: 2010-07
• Disposition First Submitted: 2011-03-31
• Disposition First Submitted QC: 2011-03-31
• Disposition First Posted: 2011-04-07
• Results First Submitted: 2011-09-09
• Results First Submitted QC: 2011-09-09
• Results First Posted: 2011-10-17
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	botulinum toxin Type A (100U); botulinum toxin Type A (200U)	botulinum toxin Type A (100U); botulinum toxin Type A (200U)
3	botulinum toxin Type A (200U)	botulinum toxin Type A (200U)
1	botulinum toxin Type A (50U); botulinum toxin Type A (200U)	botulinum toxin Type A (50U); botulinum toxin Type A (200U)
4	Normal saline (Placebo); botulinum toxin Type A (200U)	placebo; botulinum toxin Type A (200U)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence	Baseline, Week 6	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

Name	Time	Method
Change From Baseline in Maximum Cystometric Capacity (MCC)	Baseline, Week 6	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)	Baseline, Week 6	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.