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

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Biological: botulinum toxin Type A (200U); Other: Normal saline (Placebo); botulinum toxin Type A (300U); Biological: botulinum toxin Type A (300U); Other: Normal saline (Placebo); botulinum toxin Type A (200U)

• Registration Number: NCT00461292
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-13
• Study First Submitted QC: 2007-04-13
• Study First Posted: 2007-04-17
• Study Start: 2007-05
• Primary Completion: 2010-03
• Study Completion: 2010-04
• 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: COMPLETED
• Sex: All
• Target Recruitment: 275

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	botulinum toxin Type A (200U)	botulinum toxin Type A (200U)
4	Normal saline (Placebo); botulinum toxin Type A (300U)	placebo; botulinum toxin Type A (300U)
2	botulinum toxin Type A (300U)	botulinum toxin Type A (300U)
3	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 Total Score on Incontinence Quality of Life (I-QOL) Questionnaire	Baseline, Week 6	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.
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 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.