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

February 16, 2019 updated by: Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510230
        • Recruiting
        • Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Wei Zhu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Urolithiasis patients administered for active stone removal

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experiment group
All eligible patients administered for active stone removal.
Other: 24-h urine collection
Collecting 24-h urine prior and after stone removal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine pH Change
Time Frame: Change from baseline urine pH at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine oxalate excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine citrate excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine calcium excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine phosphate excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine sodium excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine potassium excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine chloride excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine creatinine excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine uric acid excretion at 4 weeks after proven stone free status
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
Time Frame: Change from baseline 24-h urine magnesium excretion at 4 weeks after proven stone free status
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

February 28, 2020

Study Completion (ANTICIPATED)

August 31, 2020

Study Registration Dates

First Submitted

January 26, 2019

First Submitted That Met QC Criteria

February 16, 2019

First Posted (ACTUAL)

February 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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