A Research Study for Patients With Overactive Bladder

Allergan313 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

313

Conditions

Overactive Bladder Urinary Incontinence

Interventions

botulinum toxin Type ABIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

PlaceboDRUG

Placebo (normal saline) injected into detrusor on Day 1

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Pittsburgh, Pennsylvania, United States

Unnamed facility

Ghent, Belgium

Unnamed facility

Victoria, British Columbia, Canada

Unnamed facility

Berlin, Germany

Unnamed facility

Warsaw, Poland

Outcomes

Primary Outcomes

Change in Number of Urinary Urge Incontinence Episodes

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.

Time frame: Baseline, Week 2, Week 6, Week 12

Secondary Outcomes

Change in Number of Micturitions

Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.

Time frame: Baseline, Week 2, Week 6, Week 12

Change in Number of Nocturia Episodes

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.

Time frame: Baseline, Week 12

Maximum Cystometric Capacity (MCC) by Urodynamic Measurements

Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters

Time frame: Baseline, Week 12

Incontinence Quality of Life Instrument (I-QOL)

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.

Time frame: Baseline, Week 2, Week 6, Week 12

Data from ClinicalTrials.gov

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