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

Sponsor
Centro de Reabilitação e Readaptação Dr. Henrique Santillo (Other)
Overall Status
Completed
CT.gov ID
NCT01477736
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Arms and Interventions

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

Outcome Measures

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 [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 [Beginning and 24 weeks of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ruiter Silva Ferreira, Dr, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
ClinicalTrials.gov Identifier:
NCT01477736
Other Study ID Numbers:
  • OXITBALM
First Posted:
Nov 22, 2011
Last Update Posted:
Nov 22, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Ruiter Silva Ferreira, Dr, Centro de Reabilitação e Readaptação Dr. Henrique Santillo
Neurogenic bladder
Urodynamic
Quality of life
Additional relevant MeSH terms:
Spinal Cord Injuries
Oxybutynin
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA

Study Results

No Results Posted as of Nov 22, 2011