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

November 19, 2011 updated by: Ruiter Silva Ferreira, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083887
        • UNICAMP, Division of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Botulinum toxin A
Drug: Oxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
Drug: Botulinum toxin A
300 U intradetrusor injection
Active Comparator: oxybutynin
Drug: Oxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
Drug: Botulinum toxin A
300 U intradetrusor injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Beginning and 24 weeks of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire
Time Frame: Beginning and 24 weeks of the study
Beginning and 24 weeks of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Investigators

  • Principal Investigator: RUITER S FERREIRA, Dr., Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 19, 2011

First Submitted That Met QC Criteria

November 19, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 19, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXITBALM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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