UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049812 |
|---|---|
| Receipt number | R000056673 |
| Scientific Title | Quality of life analysis using the WISQOL for patients with urinary stones |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/12/17 01:18:52 |
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Basic information
Public title
Quality of life analysis using the WISQOL for patients with urinary stones
Acronym
Quality of life analysis using the WISQOL for patients with urinary stones
Scientific Title
Quality of life analysis using the WISQOL for patients with urinary stones
Scientific Title:Acronym
Quality of life analysis using the WISQOL for patients with urinary stones
Region
| Japan |
Condition
Condition
urinary stones
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of surgical treatment of urinary stones on perioperative HRQOL using WISQOL
Basic objectives2
Others
Basic objectives -Others
Identification of factors affecting perioperative HRQOL in the surgical treatment of urinary stones
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The impact of surgical treatment of urinary stones on perioperative HRQOL
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age between 18 and 80 years, Japanese as the mother tongue, mental ability to provide informed consent, and being scheduled for urinary stone treatment.
Key exclusion criteria
dementia, significant vision loss, and reoperation for residual stones
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shuzo |
| Middle name | |
| Last name | Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Nephro-urology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528538266
hamamo10@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shuzo |
| Middle name | |
| Last name | Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Nephro-urology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528538266
Homepage URL
hamamo10@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
No funding was received.
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
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
0528515511
clinical_research@med.nagoya-cu.ac.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
| 2022 | Year | 12 | Month | 19 | 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
123
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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients are asked to complete the WISQOL at preoperative and 4 weeks postoperatively for surgical treatment of urinary stones.
Management information
Registered date
| 2022 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056673
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
