UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061837 |
|---|---|
| Receipt number | R000070749 |
| Scientific Title | A Prospective Interventional Study to Evaluate the Efficacy of an Application for Visualizing Nutritional Intake to Prevent Recurrence of Urinary Tract Stones |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/06/08 23:49:05 |
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Basic information
Public title
A Study to Evaluate the Efficacy of an Application for Preventing Recurrence of Urinary Tract Stones
Acronym
A Study to Evaluate the Efficacy of an Application for Preventing Recurrence of Urinary Tract Stones
Scientific Title
A Prospective Interventional Study to Evaluate the Efficacy of an Application for Visualizing Nutritional Intake to Prevent Recurrence of Urinary Tract Stones
Scientific Title:Acronym
A Prospective Interventional Study to Evaluate the Efficacy of an Application for Visualizing Nutritional Intake to Prevent Recurrence of Urinary Tract Stones
Region
| Japan |
Condition
Condition
Urolithiasis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To use an application designed to track dietary and fluid intake habits and provide nutritional counseling for patients with urinary tract stones (hereinafter referred to as the Nutritional Intake Visualization Application) to collect data on the dietary habits (intake of various nutrients) and fluid intake of these patients; to examine the impact of these factors on 24-hour urine chemistry test results and urinary tract stone recurrence; and to evaluate the effectiveness of the application, including its nutritional counseling features.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in 24-hour urine chemistry test results
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
After the study begins, participants will use a nutritional intake tracking app to collect data on their dietary habits (nutrient intake) and fluid intake. They will record data on all food and beverages consumed as thoroughly as possible during the observation period (3 years).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with recurrent upper urinary tract stones who were treated at the Department of Urology of the University Hospital within three years of the study approval date and who provided informed consent to participate in this study.
Key exclusion criteria
Patients under 20 years of age
Pregnant women
Patients whose stones consisted of calcium phosphate (alone), magnesium ammonium phosphate, cystine, or other rare components
Patients with whom communication is difficult
Patients with endocrine or metabolic disorders that lead to urinary stone formation (primary hyperparathyroidism, primary hyperoxaluria, renal tubular acidosis, sarcoidosis, intestinal hyperoxaluria, bone metabolism disorders, etc.)
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | RYUSUKE |
| Middle name | |
| Last name | DEGUCHI |
Organization
Wakayama Medical University
Division name
The department of urology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture
TEL
073-441-0637
ryusuke@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | RYUSUKE |
| Middle name | |
| Last name | DEGUCHI |
Organization
Wakayama Medical University
Division name
The department of urology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture
TEL
073-441-0637
Homepage URL
ryusuke@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama City, Wakayama Prefecture
Tel
073-441-0637
ryusuke@wakayama-med.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
| 2026 | 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
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070749
