Comparison of 24-hour Collecting Urine Prior and After Stone Removal

Urolithiasis Clinical Trial

Official title:

Metabolic Evaluation of Urolithiasis: Comparison of 24-hour Collecting Urine Prior and After Stone Removal - a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03846011
• Other study ID #: 2019-003
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Guohua Zeng, M.D.
• Phone: +8613802916676
• Email: gzgyzgh[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

Other:
• 24-h urine collection
Collecting 24-h urine prior and after stone removal surgery

Locations

Country	Name	City	State
China	Department of Urology, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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