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

Allergan416 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

416

Conditions

Overactive Bladder

Interventions

botulinum toxin Type A (200U)BIOLOGICAL

botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

botulinum toxin Type A (300U)BIOLOGICAL

botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at \> 12 weeks interval

Normal Saline (Placebo); botulinum toxin Type A (200U)OTHER

Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * History of evidence of pelvic or urologic abnormality * Previous or current diagnosis of bladder or prostate cancer * Urinary tract infection at time of enrollment

Locations (14)

Unnamed facility

Royal Oak, Michigan, United States

Unnamed facility

Randwick, New South Wales, Australia

Unnamed facility

Innsbruck, Austria

Unnamed facility

Ghent, Belgium

Outcomes

Primary Outcomes

Change From Baseline in Number of Weekly Episodes of Urinary Incontinence

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).

Time frame: Baseline, Week 6

Secondary Outcomes

Change From Baseline in Maximum Cystometric Capacity (MCC)

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.

Time frame: Baseline, Week 6

Change From Baseline in Maximum Detrusor Pressure (MDP)

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.

Time frame: Baseline, Week 6

Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire

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

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

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