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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruiter Silva Ferreira, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
ClinicalTrials.gov Identifier:
NCT01477736
First received: November 19, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Drug: Oxybutynin
Drug: Botulinum toxin A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity

Resource links provided by NLM:


Further study details as provided by Centro de Reabilitação e Readaptação Dr. Henrique Santillo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire [ Time Frame: Beginning and 24 weeks of the study ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477736

Locations
Brazil
UNICAMP, Division of Urology
Campinas, Sao Paulo, Brazil, 13083887
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Ruiter Silva Ferreira, Dr, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
ClinicalTrials.gov Identifier: NCT01477736     History of Changes
Other Study ID Numbers: OXITBALM
Study First Received: November 19, 2011
Last Updated: November 19, 2011
Health Authority: BRAZIL: AGENCIA NACIONAL DE VIGILANCIA SANITARIA

Keywords provided by Centro de Reabilitação e Readaptação Dr. Henrique Santillo:
Neurogenic bladder
Urodynamic
Quality of life

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Botulinum Toxins, Type A
Oxybutynin
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on July 31, 2014