UrolithiasisNCT03846011
Comparison of 24-hour Collecting Urine Prior and After Stone Removal
An observational study of Urolithiasis and Urinary Stone, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Urinary Stone
- What is being tested?
- 24-h urine collection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urolithiasis patients administered for active stone removal
Who may be able to join
- Patients 18 years or older
- Urolithiasis (Nephrolithiasis, Ureterolithiasis)
Who cannot join
- Patients under 18 years
- Urinary tract infection (positive urine culture prior to surgery)
- Incomplete 24h urine collection
- Pregnancy
- Residual stones after surgery
Trial locations and contacts
1 site in 1 country.
Wei Zhu, M.D. contact
China1 site, 1 recruiting
- Recruiting
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
Guohua Zeng, M.D., +8613802916676, gzgyzgh@vip.sina.com
Wei Zhu, M.D., doczw1989@126.com
About this study
Official title: 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.
Read the 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
- 24h urine composition prior and after stone removal: pH value, spec. weight, creatinine, calcium, oxalate, uric acid, citrate, magnesium, phosphate, ammonium, cysteine, sodium, potassium.
- 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.
- Conditions
- Urolithiasis, Urinary Stone
- Being tested
- 24-h urine collection
- Keywords
- urolithiasis, 24-h urine composition
- Medical subject headings
- Urolithiasis, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-h urine collectionOther
Collecting 24-h urine prior and after stone removal surgery
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | All eligible patients administered for active stone removal. Receives: Other: 24-h urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine pH Change
pH values will be determined with a glass electrode in a calibrated pH meter
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline 24-h urine magnesium excretion at 4 weeks after proven stone free status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846011
- Sponsor's protocol ID
- 2019-003
- Status last verified
- Feb 2019
- First submitted
- 26 Jan 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36779823
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Evaluation of Urolithiasis: Comparison of 24-hour Collecting Urine Prior and After Stone Removal - a Prospective Study
- ClinicalTrials.gov ID
- NCT03846011
- Acronym / sponsor ID
- 2019-003
- Conditions
- Urolithiasis, Urinary Stone
- Keywords
- urolithiasis, 24-h urine composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 24h urine composition prior and after stone removal: pH value, spec. weight, creatinine, calcium, oxalate, uric acid, citrate, magnesium, phosphate, ammonium, cysteine, sodium, potassium.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment group | – | Other: 24-h urine collectionAll eligible patients administered for active stone removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urolithiasis patients administered for active stone removal
Key inclusion criteria (2 listed)
- Patients 18 years or older
- Urolithiasis (Nephrolithiasis, Ureterolithiasis)
Key exclusion criteria (5 listed)
- Patients under 18 years
- Urinary tract infection (positive urine culture prior to surgery)
- Incomplete 24h urine collection
- Pregnancy
- Residual stones after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-h urine collectionCollecting 24-h urine prior and after stone removal surgery | Other | Experiment group |
Primary outcome
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 36779823Zhu 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.
- Individual participant dataSharing planned: Undecided
Related trials for Urolithiasis
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhu, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Urinary Stone, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guohua Zeng, M.D. (+8613802916676, gzgyzgh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine pH Change (time frame: Change from baseline urine pH at 4 weeks after proven stone free status). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.