Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Allergan548 enrolled

Overview

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

548

Conditions

Overactive Bladder

Interventions

onabotulinumtoxinABIOLOGICAL

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).

normal salineDRUG

Normal saline (placebo) injected into the detrusor at Day 1.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months * Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Criteria: * Overactive Bladder caused by neurological condition * Patient has predominance of stress incontinence * History or evidence of pelvic or urological abnormality

Locations (7)

Unnamed facility

Laguna Hills, California, United States

Unnamed facility

Ghent, Belgium

Unnamed facility

Prague, Czechia

Unnamed facility

Tübingen, Germany

Unnamed facility

Outcomes

Primary Outcomes

Change From Baseline in Number of Daily Episodes of Urinary Incontinence

A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Number of Daily Micturition Episodes

The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).

Time frame: Baseline, Week 12

Change From Baseline in Volume Voided Per Micturition

The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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