UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001422 |
|---|---|
| Receipt number | R000001694 |
| Scientific Title | Subepithelial injection of botulinum toxin A for non-neurogecic overactive bladder |
| Date of disclosure of the study information | 2008/10/14 |
| Last modified on | 2011/10/07 17:25:52 |
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Basic information
Public title
Subepithelial injection of botulinum toxin A for non-neurogecic overactive bladder
Acronym
Botulinum toxin injection in non-neurogenic OAB
Scientific Title
Subepithelial injection of botulinum toxin A for non-neurogecic overactive bladder
Scientific Title:Acronym
Botulinum toxin injection in non-neurogenic OAB
Region
| Japan |
Condition
Condition
Non-neurogenic 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 non-neurogenic 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 urge urinary incontinence 1month after treatment
Key secondary outcomes
Recurrence of urge urinary incontinence, change of bladder capacity and symptoms 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 100 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 has non-neurogenic overactive bladder.
2) Written informd consent is required.
3) One or more times a week of urge urinary incontinence was seen after antichorinergic drugs or antichorinergic drugs 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) 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.
Target sample size
45
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 | 14 | 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 | 06 | 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=R000001694
