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

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ClinicalTrials.gov Identifier: NCT01477736
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Ruiter Silva Ferreira, Centro de Reabilitação e Readaptação Dr. Henrique Santillo

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Oxybutynin Drug: Botulinum toxin A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire [ Time Frame: Beginning and 24 weeks of the study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

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

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Oxybutynin
Mandelic Acids
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents