UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040147 |
|---|---|
| Receipt number | R000045765 |
| Scientific Title | Subepithelial injection of onabotulinumtoxin A for overactive bladder |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2023/10/16 11:12:07 |
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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
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
hirotakasato911@yahoo.co.jp
Sponsor or person
Institute
Hokusuikai kinen Hospital
Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Department Urology, Hokusuikai kinen Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
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
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045765
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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