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Completed

NCT Number: NCT01477736

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNICAMP, Division of Urology

Campinas, São Paulo, 13083887, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxybutynin

Drug

5 mg of immediate-release oxybutynin orally 3 times daily

Botulinum toxin A

Drug

300 U intradetrusor injection

Primary outcomes

  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 outcomes

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

    Time frame: Beginning and 24 weeks of the study

Sponsors and collaborators

Lead sponsor

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 22, 2011
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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