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

Centro de Reabilitação e Readaptação Dr. Henrique Santillo68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

OxybutyninDRUG

5 mg of immediate-release oxybutynin orally 3 times daily

Botulinum toxin ADRUG

300 U intradetrusor injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UNICAMP, Division of Urology

Campinas, São Paulo, Brazil

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

Secondary Outcomes

The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire

Time frame: Beginning and 24 weeks of the study

Data from ClinicalTrials.gov

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