A Research Study for Patients With Overactive Bladder

Phase 2

Completed

• Conditions: Overactive Bladder; Urinary Incontinence
• Interventions: Drug: Placebo; Biological: botulinum toxin Type A

• Registration Number: NCT00168454
• Lead Sponsor: Allergan

Brief Summary

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2008-01
• Study Completion: 2008-06
• Results First Submitted: 2009-09-02
• Results First Submitted QC: 2010-01-15
• Results First Posted: 2010-02-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-11
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

• Must be between 18-85 years old
• Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
• Must weigh at least 50 kg (110 lbs)
• Must be willing and able to record information regarding bladder function into a diary (provided)
• Must be willing and able to complete the entire course of the study

Exclusion Criteria

• Cannot currently be catheterizing as a way to control incontinence
• Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (normal saline) injected into detrusor on Day 1
BOTOX 50 U	botulinum toxin Type A	botulinum toxin Type A 50 U injected into detrusor on Day 1
BOTOX 100 U	botulinum toxin Type A	botulinum toxin Type A 100 U injected into detrusor on Day 1
BOTOX 150 U	botulinum toxin Type A	botulinum toxin Type A 150 U injected into detrusor on Day 1
BOTOX 200 U	botulinum toxin Type A	botulinum toxin Type A 200 U injected into detrusor on Day 1
BOTOX 300 U	botulinum toxin Type A	botulinum toxin Type A 300 U injected into detrusor on Day 1

Primary Outcome Measures

Name	Time	Method
Change in Number of Urinary Urge Incontinence Episodes	Baseline, Week 2, Week 6, Week 12	Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.

Secondary Outcome Measures

Name	Time	Method
Change in Number of Nocturia Episodes	Baseline, Week 12	Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.
Incontinence Quality of Life Instrument (I-QOL)	Baseline, Week 2, Week 6, Week 12	Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.
Change in Number of Micturitions	Baseline, Week 2, Week 6, Week 12	Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.
Maximum Cystometric Capacity (MCC) by Urodynamic Measurements	Baseline, Week 12	Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters