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

Information source: Centro de Reabilitação e Readaptação Dr. Henrique Santillo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury

Intervention: Oxybutynin (Drug); Botulinum toxin A (Drug)

Phase: N/A

Status: Completed

Sponsored by: Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Official(s) and/or principal investigator(s):
RUITER S FERREIRA, Dr., Principal Investigator, Affiliation: Division of Urology of State University of Campinas, Division of Urology of Centro de Reabilitaçao e Readapatacao Dr. Henrique Santillo


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.

Clinical Details

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

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

Primary outcome: 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

Secondary outcome: The secondary outcome measure was quality of life as measured by the Qualiveen questionnaire


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

UNICAMP, Division of Urology, Campinas, Sao Paulo 13083887, Brazil
Additional Information

Related publications:

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.

Starting date: January 2009
Last updated: November 19, 2011

Page last updated: August 23, 2015

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