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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00575016

Overactive Bladder

TERMINATED PHASE2

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

NCT00461292

Overactive Bladder

COMPLETED PHASE3

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

NCT00311376

Overactive Bladder

COMPLETED PHASE3

A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

NCT00876447

Overactive Bladder

COMPLETED PHASE3

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

NCT00910845

Overactive Bladder

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

botulinum toxin Type A 200U

Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A injection into the detrusor.

botulinum toxin Type A 300U

Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A injection into the detrusor.

Placebo/botulinum toxin Type A 200U

Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).

Group Type OTHER

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A injection into the detrusor.

Normal Saline (Placebo)

Intervention Type DRUG

Placebo (Normal Saline) injection into the detrusor.

Placebo/botulinum toxin Type A 300U

Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).

Group Type OTHER

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A injection into the detrusor.

Normal Saline (Placebo)

Intervention Type DRUG

Placebo (Normal Saline) injection into the detrusor.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

botulinum toxin Type A

Botulinum toxin Type A injection into the detrusor.

Intervention Type BIOLOGICAL

Normal Saline (Placebo)

Placebo (Normal Saline) injection into the detrusor.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BOTOX® onabotulinumtoxinA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
* Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Symptomatic or untreated urinary tract infection at time of enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No