UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055031 |
|---|---|
| Receipt number | R000062869 |
| Scientific Title | Biofeedback Therapy in the Treatment of Children with Dysfunctional Voiding: Does the Presence of Overactive Bladder Affect Treatment Outcomes? |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2024/07/20 20:23:52 |
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Basic information
Public title
Efficacy of Biofeedback Therapy in the Treatment of Dysfunctional Voiding
Acronym
Efficacy of Biofeedback Therapy in the Treatment of Dysfunctional Voiding
Scientific Title
Biofeedback Therapy in the Treatment of Children with Dysfunctional Voiding: Does the Presence of Overactive Bladder Affect Treatment Outcomes?
Scientific Title:Acronym
Biofeedback Therapy in the Treatment of Children with Dysfunctional Voiding: Does the Presence of Overactive Bladder Affect Treatment Outcomes?
Region
| Asia(except Japan) |
Condition
Condition
The aim of the study is to detect the efficacy of biofeedback and to show the effect of overactive bladder on treatment
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of biofeedback therapy for the treatment of dysfunctional voiding in children.
To show effect of overactive bladder on the treatment success of biofeedback therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resolution of uroflowmetry findings and clinical symptoms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 5 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
To have the diagnosis of dysfunctional voiding
To complete BF sessions
Key exclusion criteria
Presence of anatomical or neurological problems
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Furkan Adem |
| Middle name | |
| Last name | Canbaz |
Organization
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Division name
Pediatric Surgery and pediatric urology
Zip code
34785
Address
Istanbul
TEL
+905534800998
ademcanbaz@gmail.com
Public contact
Name of contact person
| 1st name | Furkan Adem |
| Middle name | |
| Last name | Canbaz |
Organization
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Division name
Pediatric surgery and pediatric urology
Zip code
34785
Address
Istanbul
TEL
+905534800998
Homepage URL
ademcanbaz@gmail.com
Sponsor or person
Institute
Furkan Adem Canbaz
Institute
Department
Personal name
Funding Source
Organization
None
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
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital Ethics Committee
Address
Emek Mahallesi, Namik Kemal Cad. No:54, 34785 Sancaktepe / Istanbul
Tel
+9002166063300
istanbuleah35.bsh@saglik.gov.tr
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
| 2025 | Year | 08 | 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
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients diagnosed with dysfunctional voiding and treated by biofeedback therapy between November 2022-November 2023 will be evaluated.
Management information
Registered date
| 2024 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062869
