A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity

Centro de Reabilitação e Readaptação Dr. Henrique Santillo1 site in 1 country68 target enrollmentJanuary 2009

ConditionsSpinal Cord Injury

InterventionsOxybutynin Botulinum toxin A

DrugsOxybutynin Botulinum toxin A

Overview

Phase: N/A
Intervention: Oxybutynin
Conditions: Spinal Cord Injury
Sponsor: Centro de Reabilitação e Readaptação Dr. Henrique Santillo
Enrollment: 68
Locations: 1
Primary Endpoint: The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type A on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

November 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Responsible Party

Principal Investigator

Ruiter Silva Ferreira

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Eligibility Criteria

Inclusion Criteria

•Spinal cord injury
•Detrusor overactivity
•Age over 18 years
•Spinal cord injury at least 12 months duration
•Undergoing regular clean intermittent catheterisation

Exclusion Criteria

•Pregnancy
•Desire to become pregnant during the study period
•Breastfeeding
•Blood coagulation disorder
•Neuromuscular transmission disorder
•Use of any intravesical pharmacologic agents
•Previous use of botulinum toxin A

Arms & Interventions

Botulinum toxin A

Intervention: Oxybutynin

Botulinum toxin A

Intervention: Botulinum toxin A

oxybutynin

Intervention: Oxybutynin

oxybutynin

Intervention: Botulinum toxin A

Outcomes

Primary Outcomes

The primary study outcome measure was the variation mean in the number of episodes of urinary incontinence per 24 hours, maximum cystometric capacity, maximum detrusor pressure and bladder compliance

Time Frame: Beginning and 24 weeks of the study