UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059056 |
|---|---|
| Receipt number | R000067549 |
| Scientific Title | Determining Optimal Conditions for Compression Stockings Used in the Treatment of Nocturia |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/11 11:03:43 |
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Basic information
Public title
Determining Optimal Conditions for Compression Stockings Used in the Treatment of Nocturia
Acronym
Determining Optimal Conditions for Compression Stockings Used in the Treatment of Nocturia
Scientific Title
Determining Optimal Conditions for Compression Stockings Used in the Treatment of Nocturia
Scientific Title:Acronym
Determining Optimal Conditions for Compression Stockings Used in the Treatment of Nocturia
Region
| Japan |
Condition
Condition
Nocturia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to determine the optimal length and appropriate compression pressure of compression stockings used for treating nocturia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of nighttime frequency in the frequency volume chart
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing compression stockings during the daytime for one month
Interventions/Control_2
Wearing compression stockings during the daytime for one month under different conditions for Intervention 1
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
Patients with nocturia (two or more night time frequency)
Patients aged 20 years or older at the time of consent acquisition
Patients who did not refuse participation in this study
Key exclusion criteria
Patients with hypersensitivity to the materials in compression stockings
Patients with a history of urinary tract infections (e.g., cystitis), urinary tract stones (e.g., ureteral stones, urethral stones, bladder stones), urethral disorders (e.g., urethral polyps, urethral diverticula), or recurrent urinary tract infections (occurring three or more times within 180 days prior to compression stocking use)
Patients who underwent pelvic organ surgery (e.g., radical hysterectomy, radical rectal cancer resection, extensive pelvic lymph node dissection) within 30 days prior to compression stocking application
Patients who received physical therapy (pelvic floor muscle training, feedback training, biofeedback training, vaginal cones, bladder training, electrical stimulation therapy, magnetic stimulation therapy, etc.) within 30 days prior to wearing compression stockings
Patients with severe arterial circulatory disorders, congestive heart failure, or painful cyanotic varicose veins
Patients with suppurative phlebitis
Other patients deemed unsuitable for this study by the principal investigator or others
Target sample size
40
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
E 2285, Sawara, Katori, Chiba
TEL
0478-54-1231
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
E 2285, Sawara, Katori, Chiba
TEL
0478-54-1231
Homepage URL
robert_chibariyo0072@yahoo.co.jp
Sponsor or person
Institute
Chiba Prefectural Sawara Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba Prefectural Sawara Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Prefectural Sawara Hospital
Address
E 2285, Sawara, Katori, Chiba
Tel
0478-54-1231
robert_chibariyo0072@yahoo.co.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
| 2025 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | 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
| 2025 | 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=R000067549
