UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025019 |
|---|---|
| Receipt number | R000028789 |
| Scientific Title | A Study of novel method for Enuresis |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2023/06/05 08:39:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study of novel method for Enuresis
Acronym
A Study of novel method for Enuresis
Scientific Title
A Study of novel method for Enuresis
Scientific Title:Acronym
A Study of novel method for Enuresis
Region
| Japan |
Condition
Condition
nocturnal enuresis
Classification by specialty
| Pediatrics | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of novel treatment for enuresis.
We research the number and quantity of enuresis and the patient satisfaction for treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Number and quantity of enuresis.(4.8.12 weeks after start of treatment)
Score evaluation of patient satisfaction for treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
4-12 weeks
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
| 7 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nocturnal enuresis
Key exclusion criteria
Day time incontinence
Constipation
Severe heart disease
Skin disorders
A history of convulsive seizures
Patients who are predicted to develop convulsive seizures
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Naitoh |
Organization
Kyoto prefectural university of medicine
Division name
Urology
Zip code
Address
Kajicho-kamigyoku,kyoto
TEL
075-251-5595
naitoh@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Naitoh |
Organization
Kyoto prefectural university of medicine
Division name
Urology
Zip code
Address
Kajicho-kamigyoku,kyoto
TEL
075-251-5595
Homepage URL
naitoh@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural university of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028789
