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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477736
• Other study ID #: OXITBALM
• Status: Completed
• Phase: N/A
• First received: November 19, 2011
• Last updated: November 19, 2011
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2011
• Source: Centro de Reabilitação e Readaptação Dr. Henrique Santillo
• Contact: n/a
• Is FDA regulated: No
• Health authority: BRAZIL: AGENCIA NACIONAL DE VIGILANCIA SANITARIA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Oxybutynin
5 mg of immediate-release oxybutynin orally 3 times daily
• Botulinum toxin A
300 U intradetrusor injection

Locations

Country	Name	City	State
Brazil	UNICAMP, Division of Urology	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Karsenty G, Denys P, Amarenco G, De Seze M, Gamé X, Haab F, Kerdraon J, Perrouin-Verbe B, Ruffion A, Saussine C, Soler JM, Schurch B, Chartier-Kastler E. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol. 2008 Feb;53(2):275-87. Epub 2007 Oct 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire		Beginning and 24 weeks of the study	No

External Links

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