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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040147
Receipt No. R000045765
Scientific Title Subepithelial injection of onabotulinumtoxin A for overactive bladder
Date of disclosure of the study information 2020/05/01
Last modified on 2021/10/14

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Basic information
Public title Subepithelial injection of onabotulinumtoxin A for overactive bladder
Acronym Onabotulinumtoxin A injection in overactive bladder
Scientific Title Subepithelial injection of onabotulinumtoxin A for overactive bladder
Scientific Title:Acronym Onabotulinumtoxin A injection in overactive bladder
Region
Japan

Condition
Condition Refractory overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effect and safety of subepithelial injection of Botulinum toxin A for patients with refractory overactive bladder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the number of daily urinary incontinence at week 12 after treatment
Key secondary outcomes Change of the number of urinary urgency incontinence, micturition, nocturia and evaluation of adverse event.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Sato
Organization Hokusuikai Kinen Hospital
Division name department of urology
Zip code 3100035
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
TEL 0293033003
Email hirotakasato911@yahoo.co.jp

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Sato
Organization Hokusuikai Kinen Hospital
Division name department of urology
Zip code 3100035
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
TEL 0293033003
Homepage URL
Email hirotakasato911@yahoo.co.jp

Sponsor
Institute Hokusuikai kinen Hospital
Department of Urology
Institute
Department

Funding Source
Organization Department Urology, Hokusuikai kinen Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokusuikai Kinen Hospital
Address 3-2-1, Higashihara-cyo, Mito-city, Ibaraki-ken
Tel 0293033003
Email hirotakasato911@yahoo.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 01 Month 15 Day
Date of IRB
2020 Year 03 Month 26 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
2023 Year 07 Month 31 Day
Date trial data considered complete
2023 Year 07 Month 31 Day
Date analysis concluded
2023 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2020 Year 04 Month 13 Day
Last modified on
2021 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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