UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055481 |
|---|---|
| Receipt number | R000063392 |
| Scientific Title | Investigation of the usefulness of air-charged catheters in measuring urethral pressure profile. |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/09/11 09:34:24 |
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Basic information
Public title
Investigation of the usefulness of air-charged catheters in measuring urethral pressure profile.
Acronym
Investigation of the usefulness of air-charged catheters in measuring urethral pressure profile.
Scientific Title
Investigation of the usefulness of air-charged catheters in measuring urethral pressure profile.
Scientific Title:Acronym
Investigation of the usefulness of air-charged catheters in measuring urethral pressure profile.
Region
| Japan |
Condition
Condition
Urinary incontinence
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the usefulness of air-charged catheters in urethral pressure profiles.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate the accuracy of urethral pressure profiles in air-charged catheters compared to water filled catheters.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum urethral closure pressure
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with urinary incontinence who gave consent for the study and had urethral pressure profile
Key exclusion criteria
Patients who have requested not to participate in the study by themselves, their parents, or guardians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kanya |
| Middle name | |
| Last name | Kaga |
Organization
Chiba Prefectural Sawara Hospital
Division name
Department of Urology
Zip code
287-0003
Address
E2285, Sawara, Katori, Chiba, Japan
TEL
0478541231
robert_chibariyo0072@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kanya |
| Middle name | |
| Last name | Kaga |
Organization
Chiba Prefectural Sawara Hospital
Division name
Department of Urology
Zip code
287-0003
Address
E2285, Sawara, Katori, Chiba, Japan
TEL
0478541231
Homepage URL
robert_chibariyo0072@yahoo.co.jp
Sponsor or person
Institute
Chiba Prefectural Sawara Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Chiba Prefectural Sawara Hospital
Address
E2285, Sawara, Katori, Chiba, Japan
Tel
0478541231
d.szk18@pref.chiba.lg.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
| 2024 | Year | 09 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the accuracy of conventional and air-charged catheter-based methods of urethral pressure profile.
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063392
