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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03846011
Enrollment
100
Registered
2019-02-19
Start date
2019-03-01
Completion date
2020-08-31
Last updated
2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stone, Urolithiasis

Keywords

urolithiasis, 24-h urine composition

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.

Detailed description

Background As the metabolic evaluation is an essential part of diagnostic and recurrence prevention of urolithiasis, the current EAU Guidelines, as well as the German S2k guidelines therefore suggest 24-hour urine collection, done twice. This 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. 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. This could simplify the diagnostic and make this essential information available for more patients suffering from urolithiasis. Hypothesis Null hypothesis: The analyzed parameters in the 24-hour urine prior and after complete stone removal differ from each other Alternative hypothesis: The analyzed parameters in the 24-hour urine prior and after complete stone removal do not differ from each other Primary endpoint: The difference of the analyzed parameters prior and after complete stone removal Parameters to be collected 1. 24h urine composition prior and after stone removal: pH value, spec. weight, creatinine, calcium, oxalate, uric acid, citrate, magnesium, phosphate, ammonium, cysteine, sodium, potassium. 2. Secondary: Age, sex, body mass index, stone composition analyzed by infrared spectroscopy, urine culture, comorbidities (diabetes mellitus, hypertension, …), degree of hydronephrosis, serum electrolytes, blood urea nitrogen, serum creatinine, first manifestation or recurrent disease Methods * After assessing inclusion and exclusion criteria, all eligible patients administered for active stone removal are included in this study. * Prior to surgery, a 24-hour urine collection need to be performed (not longer than 2 month). * Post-operatively stone free status is assessed by NCCT, in ureterolithiasis only if stone free status is uncertain. * 4 weeks after proven stone free status the post surgical 24h urine collection is performed. * If a ureter stent was placed, the 24-hour urine collection is performed 4 weeks after stent removal. * All 24-hour collection are performed as outpatients. Patients will be asked to drink and eat normally when they do their urine collection. Urinary volume is measured as a marker of liquid consumption, sodium as a marker of salt intake. Sample size As no available data to show the difference of urine composition prior or after surgery, the study will enroll 100 participants first to get preliminary data. Then the final sample size will be determined by the preliminary data. Statistical Analysis: Comparisons of the urine compositions before and after stone removal will be performed using the Student's t-test for continuous variables and chi-squared for categorical variables.

Interventions

OTHER24-h urine collection

Collecting 24-h urine prior and after stone removal surgery

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 18 years or older * Urolithiasis (Nephrolithiasis, Ureterolithiasis)

Exclusion criteria

* Patients under 18 years * Urinary tract infection (positive urine culture prior to surgery) * Incomplete 24h urine collection * Pregnancy * Residual stones after surgery

Design outcomes

Primary

MeasureTime frameDescription
Urine pH ChangeChange from baseline urine pH at 4 weeks after proven stone free statuspH values will be determined with a glass electrode in a calibrated pH meter
24-h Urine oxalate excretion changeChange from baseline 24-h urine oxalate excretion at 4 weeks after proven stone free statusUrine oxalate will be measured using ion exchange chromatography
24-h Urine citrate excretion changeChange from baseline 24-h urine citrate excretion at 4 weeks after proven stone free statusUrine citrate will be measured using ion exchange chromatography
24-h Urine calcium excretion changeChange from baseline 24-h urine calcium excretion at 4 weeks after proven stone free statusUrine calcium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine phosphate excretion changeChange from baseline 24-h urine phosphate excretion at 4 weeks after proven stone free statusUrine phosphate will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine sodium excretion changeChange from baseline 24-h urine sodium excretion at 4 weeks after proven stone free statusUrine sodium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine potassium excretion changeChange from baseline 24-h urine potassium excretion at 4 weeks after proven stone free statusUrine potassium will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine chloride excretion changeChange from baseline 24-h urine chloride excretion at 4 weeks after proven stone free statusUrine chloride will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine creatinine excretion changeChange from baseline 24-h urine creatinine excretion at 4 weeks after proven stone free statusUrine creatinine will be measured by Unicel DxC 600 synchronic biochemical detecting system.
24-h Urine uric acid excretion changeChange from baseline 24-h urine uric acid excretion at 4 weeks after proven stone free statusUrine uric acid will be measured using Beckman coulter AU680 automatic biochemistry analyzer.
24-h Urine magnesium excretion changeChange from baseline 24-h urine magnesium excretion at 4 weeks after proven stone free statusUrine magnesium will be measured using Beckman coulter AU680 automatic biochemistry analyzer.

Countries

China

Contacts

Primary ContactGuohua Zeng, M.D.
gzgyzgh@vip.sina.com+8613802916676
Backup ContactWei Zhu, M.D.
doczw1989@126.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026