Comparison of 24-hour Collecting Urine Prior and After Stone Removal
Metabolic Evaluation of Urolithiasis: Comparison of 24-hour Collecting Urine Prior and After Stone Removal - a Prospective Study
1 other identifier
observational
100
1 country
1
Brief Summary
The metabolic evaluation is crucial for determining possible underlying diseases causing stone growth and to consider the lifestyle changes or medical prophylaxis needed to prevent or at least reduce stone recurrence. 24-hour urine collection is the main part of the metabolic evaluation. The time point is suggested between 3 weeks and 3 month after stone removal, but so far there are no studies comparing 24-hour urine prior and after stone removal. In this study, investigators would like to analyze parameters in the 24-hour urine prior and after complete stone removal to see whether metabolic status can be evaluated no matter stone free or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFebruary 19, 2019
February 1, 2019
12 months
January 26, 2019
February 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Urine pH Change
pH values will be determined with a glass electrode in a calibrated pH meter
Change from baseline urine pH at 4 weeks after proven stone free status
24-h Urine oxalate excretion change
Urine oxalate will be measured using ion exchange chromatography
Change from baseline 24-h urine oxalate excretion at 4 weeks after proven stone free status
24-h Urine citrate excretion change
Urine citrate will be measured using ion exchange chromatography
Change from baseline 24-h urine citrate excretion at 4 weeks after proven stone free status
24-h Urine calcium excretion change
Urine calcium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Change from baseline 24-h urine calcium excretion at 4 weeks after proven stone free status
24-h Urine phosphate excretion change
Urine phosphate will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Change from baseline 24-h urine phosphate excretion at 4 weeks after proven stone free status
24-h Urine sodium excretion change
Urine sodium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Change from baseline 24-h urine sodium excretion at 4 weeks after proven stone free status
24-h Urine potassium excretion change
Urine potassium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Change from baseline 24-h urine potassium excretion at 4 weeks after proven stone free status
24-h Urine chloride excretion change
Urine chloride will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Change from baseline 24-h urine chloride excretion at 4 weeks after proven stone free status
24-h Urine creatinine excretion change
Urine creatinine will be measured by Unicel DxC 600 synchronic biochemical detecting system.
Change from baseline 24-h urine creatinine excretion at 4 weeks after proven stone free status
24-h Urine uric acid excretion change
Urine uric acid will be measured using Beckman coulter AU680 automatic biochemistry analyzer.
Change from baseline 24-h urine uric acid excretion at 4 weeks after proven stone free status
24-h Urine magnesium excretion change
Urine magnesium will be measured using Beckman coulter AU680 automatic biochemistry analyzer.
Change from baseline 24-h urine magnesium excretion at 4 weeks after proven stone free status
Study Arms (1)
Experiment group
All eligible patients administered for active stone removal.
Interventions
Collecting 24-h urine prior and after stone removal surgery
Eligibility Criteria
Urolithiasis patients administered for active stone removal
You may qualify if:
- Patients 18 years or older
- Urolithiasis (Nephrolithiasis, Ureterolithiasis)
You may not qualify if:
- Patients under 18 years
- Urinary tract infection (positive urine culture prior to surgery)
- Incomplete 24h urine collection
- Pregnancy
- Residual stones after surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
Related Publications (1)
Zhu W, Zhang X, Lu S, Ozsoy M, Zhou Z, Huang Z, Ai G, Zeng G. Comparison of 24-hour urine composition prior to and after stone removal in nephrolithiasis: a prospective observational study. Minerva Urol Nephrol. 2024 Jun;76(3):351-356. doi: 10.23736/S2724-6051.22.05164-3. Epub 2023 Feb 13.
PMID: 36779823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the department of urology
Study Record Dates
First Submitted
January 26, 2019
First Posted
February 19, 2019
Study Start
March 1, 2019
Primary Completion
February 28, 2020
Study Completion
August 31, 2020
Last Updated
February 19, 2019
Record last verified: 2019-02