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

Centro de Reabilitação e Readaptação Dr. Henrique Santillo

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Drug: Botulinum toxin A; Drug: Oxybutynin

Study type: Interventional

Funder types: Other

Identifiers

NCT01477736

OXITBALM

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Botulinum toxin A

Active Comparator group

Treatment:

Drug: Oxybutynin

Drug: Botulinum toxin A

oxybutynin

Active Comparator group

Treatment:

Drug: Oxybutynin

Drug: Botulinum toxin A