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Subepithelial injection of onabotulinumtoxin A for overactive bladder

Subepithelial injection of onabotulinumtoxin A for overactive bladder - Onabotulinumtoxin A injection in overactive bladder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040147
Enrollment
40
Registered
2020-05-01
Start date
2020-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory overactive bladder

Interventions

After solving Botulinum toxin A 100 units by normal saline 10 mL, 20 sites in the detrusor muscle using injection needle, avoiding the trigone of the bladder.

Sponsors

Hokusuikai kinen Hospital Department of Urology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients has non-neurogenic overactive bladder. 2)written informed consent is required. 3)At least twice a week of urinary urge incontinence was seen after anticholinergics and/or beta3-adrenergic receptor agonists could not be continued because of adverse effects.

Exclusion criteria

Exclusion 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) The patient has predominantly stress urinary incontinence. 7) The patient has active urinary tract infection, malignance and/or bladder stone. 8) The patient is pregnant or breast-feed, or have possibility of such matter within 1 year. 9) The patient is diagnosed as having myasthenia gravis, Lambert-Eaton syndromeconduct , amyotrophic lateral sclerosis. 10)The patient has disturbance of swallowing and/or respiration. 11)The patient has mental and/or cognitive disturbance to conduct the clinical trial. 12) The patient is judged as being unsuitable for the trial by the researcher.

Design outcomes

Primary

MeasureTime frame
Change of the number of daily urinary incontinence at week 12 after treatment

Secondary

MeasureTime frame
Change of the number of urinary urgency incontinence, micturition, nocturia and evaluation of adverse event.

Countries

Japan

Contacts

Public ContactHirotaka Sato

Hokusuikai Kinen Hospital department of urology

hirotakasato911@yahoo.co.jp0293033003

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026