Subepithelial injection of botulinum toxin A for non-neurogecic overactive bladder

UMIN ID: UMIN000001422

Registered date:14/10/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Non-neurogenic overactive bladder
• Date of first enrollment: 2008/06/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After solving Botulinum toxin A 100 units by normal saline 15ml, 30 subepithelial injections avoiding injection into trigone are performed.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) The patient has apparent neurogenic diseases causing urinary tract symptoms. 2) The patient underwent treatment with botulinum toxin A. 3) The patient underwent the surgery of lower urinary tract within 1 year. 4) Postvoid residual urine is 100ml or greater. 5) The patient has apparent lower urinary tract obstruction and/or weak detrusor. 6) Average voiding volume are 200ml or greater on frequency-volume chart. 7) The patient has stress urinary incontinence and/or functional urinary incontinence. 8) The patient has active urinary tract infection, malignance and/or bladder stone. 9) The patient is pregnant or breast-feed, or have possibility of such matter within 1 year. 10) The patient is diagnosed as having myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis. 11) The patient has disturbance of swallowing and/or respiration. 12) The patitent has mental and/or cognitive disturbance to conduct the clinical trial. 13) 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