UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001421 |
|---|---|
| Receipt number | R000001693 |
| Scientific Title | Subepithelial injection of botulinum toxin A for neurogecic detrusor overactivity (NDO) due to spinal cord injury |
| Date of disclosure of the study information | 2008/10/10 |
| Last modified on | 2011/10/07 17:18:18 |
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Basic information
Public title
Subepithelial injection of botulinum toxin A for neurogecic detrusor overactivity (NDO) due to spinal cord injury
Acronym
Botulinum toxin injection in NDO
Scientific Title
Subepithelial injection of botulinum toxin A for neurogecic detrusor overactivity (NDO) due to spinal cord injury
Scientific Title:Acronym
Botulinum toxin injection in NDO
Region
| Japan |
Condition
Condition
Neurogenic detrusor overactivity
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 neurogenic bladder due to spinal cord injury
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the number of urge/reflex urinary incontinence 1month after treatment
Key secondary outcomes
Recurrence of urge/reflex urinary incontinence, change of bladder capacity after treatment
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 200 units by normal saline 15ml, 30 subepithelial injections avoiding injection into trigone are performed.
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) Patient suffered from spinal cord injury.
2) Detrusor overactivity was confirmed by cystometrogram.
3) Written informed consent is required.
4) One or more times a week of urge/reflex urinary incontinence was seen after antichorinergic drugs or antichorinergic drugs could not be continued because of adverse effects.
Key exclusion 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.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kikuo Okamura |
Organization
National Center for Geriatrics & Gerontology
Division name
Division of Urology, Department of Surgery & Intensive Care
Zip code
Address
36-3, Gengo Morioka-cho Obu Aichi, Japan
TEL
0562-46-2311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kikuo Okamura |
Organization
National Center for Geriatrics & Gerontology
Division name
Division of Urology, Department of Surgery & Intensive Care
Zip code
Address
36-3, Gengo Morioka-cho Obu Aichi, Japan
TEL
0562-46-2311
Homepage URL
kokamura@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics & Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare,Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo University
Name of secondary funder(s)
Nagoya University
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 09 | Day |
Last modified on
| 2011 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001693
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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