Subepithelial injection of botulinum toxin A for neurogecic detrusor overactivity (NDO) due to spinal cord injury

UMIN ID: UMIN000001421

Registered date:10/10/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Neurogenic detrusor overactivity
• Date of first enrollment: 2008/07/01
• Target sample size: 26
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After solving Botulinum toxin A 200 units by normal saline 15ml, 30 subepithelial injections avoiding injection into trigone are performed.

Outcome(s)

• Primary Outcome: Change of the number of urge/reflex urinary incontinence 1month after treatment
• Secondary Outcome: Recurrence of urge/reflex urinary incontinence, change of bladder capacity after treatment

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) The patient underwent the surgery such as bladder augmentation. 2) The patient underwent the treamtment using botulinum toxin A. 3) The patient underwent the surgery of lower urinary tract within 1 year. 4) The patient had symptomatic urinary tract infection, malignancy and bladder stone. 5) The patient is pregnant or breast-feed, or have possibility of such matter within 1 year. 6) The patient is diagnosed as having myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis. 7) The patient has disturbance of swallowing and/or respiration. 8) The patient has mental and/or cognitive disturbance to conduct clinical trial. 9) The patient is judged as being unsuitable for the trial by the researcher.

Related Information

• Primary Sponsor: National Center for Geriatrics & Gerontology
• Secondary Sponsor: Tokyo University
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Japan,Nagoya University