UrolithiasisPhase 2/3NCT06819553
A Randomized Clinical Trial to Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones
A Phase 2/3 study testing Oral Potassium Citrate in people with Urolithiasis and Stone Ureter, run by Zagazig University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to evaluate the efficacy of oral potassium citrate in reducing ureteral stent encrustation following ureteroscopy for uric acid kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Stone Ureter
- What is being tested?
- Oral Potassium Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2024to 1 Mar 2025
- Phase
- Phase 2/3
- 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
Inclusion Criteria (Participants must meet all of the following criteria to be eligible)
- Age: ≥18 years old.
- Diagnosis: Patients undergoing ureteral stenting post-ureteroscopy for uric acid kidney stones.
- Urinary pH: ≤5.5 at baseline (acidic urine).
- Willingness to Participate: Patients who provide informed consent to participate in the study.
Exclusion Criteria (Participants will be excluded if they meet any of the following criteria) Renal Function: Patients with significantly impaired kidney function (elevated creatinine beyond normal limits).
Infections: History of febrile urinary tract infection (UTI) at the time of enrollment.
Metabolic Disorders:
Chronic kidney disease (CKD) Stage 3 or higher. History of hyperkalemia. Pregnancy: Pregnant or breastfeeding women. Residual Stones: Patients with residual stone burden after ureteroscopy that may confound outcomes.
Medication Interference: Patients on medications that significantly alter urinary pH (e.g., sodium bicarbonate, acetazolamide) or those contraindicated with potassium citrate.
Other Severe Comorbidities: Any condition that, in the investigator's judgment, would interfere with study participation or pose excessive risk.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine - Zagazig University
Zagazig, Sharqia Province, 44511
About this study
Official title: Efficacy of Oral Potassium Citrate in Reducing Ureteral Stent Encrustation Post-Ureteroscopy
This randomized clinical trial aims to evaluate the efficacy of oral potassium citrate in reducing ureteral stent encrustation following ureteroscopy for uric acid kidney stones. The study will assess whether potassium citrate, by raising urinary pH, can prevent encrustation on stents, potentially improving patient outcomes and reducing complications.
Read the detailed description
Urolithiasis, particularly uric acid stones, is a prevalent condition with increasing incidence due to factors such as obesity and dietary habits. Ureteroscopy with stent placement is a common intervention for managing ureteral stones. However, the indwelling stents are prone to encrustation, which can lead to significant complications, including infection, obstruction, and discomfort for patients.
Potassium citrate, an alkalinizing agent, has been shown to prevent uric acid stone formation by raising urinary pH and dissolving existing stones. This trial aims to determine whether potassium citrate can also reduce encrustation on ureteric stents following ureteroscopy for uric acid stones.
In this prospective, randomized, controlled trial, patients undergoing ureteroscopy with stent placement for uric acid stones will be randomly assigned to either the intervention group (receiving potassium citrate) or a control group. The primary outcome is the rate of stent encrustation, which will be assessed using a modified scoring system after stent removal. Secondary outcomes include serum electrolyte levels, adverse events, and changes in urinary pH. All patients will be monitored regularly for changes in urine pH and adverse events during the study.
The findings from this trial may provide valuable insights into the role of potassium citrate in preventing ureteric stent encrustation, ultimately improving patient outcomes and reducing the need for additional interventions.
- Conditions
- Urolithiasis, Stone Ureter
- Being tested
- Oral Potassium Citrate
- Keywords
- stone disease, Oral Potassium Citrate
- Medical subject headings
- Urolithiasis, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Potassium CitrateDrug
Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Experimental Arm)Patients receiving potassium citrate. | Experimental | Oral potassium citrate (15 meq twice daily) to maintain urinary pH between 6.8 and 7.2. Receives: Drug: Oral Potassium Citrate |
| control arm | No intervention | No oral potassium citrate or any other treatment for stent encrustation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system.
The degree of encrustation on ureteral stents will be assessed using a modified encrustation scoring system upon stent removal. Encrustation severity will be categorized based on deposition on the stent surface, graded from no encrustation to severe encrustation.
Stents will be examined macroscopically and, if applicable, under microscopy for calcium and uric acid deposits.
Measured: Stent removal, typically 4-6 weeks after ureteroscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start3 Nov 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819553
- Sponsor's protocol ID
- 571/13-Aug-2024
- Status last verified
- Aug 2024
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Potassium Citrate in Reducing Ureteral Stent Encrustation Post-Ureteroscopy
- ClinicalTrials.gov ID
- NCT06819553
- Acronym / sponsor ID
- 571/13-Aug-2024
- Conditions
- Urolithiasis, Stone Ureter
- Keywords
- stone disease, Oral Potassium Citrate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
This randomized clinical trial aims to evaluate the efficacy of oral potassium citrate in reducing ureteral stent encrustation following ureteroscopy for uric acid kidney stones. The study will assess whether potassium citrate, by raising urinary pH, can prevent encrustation on stents, potentially improving patient outcomes and reducing complications.
Detailed description
Urolithiasis, particularly uric acid stones, is a prevalent condition with increasing incidence due to factors such as obesity and dietary habits. Ureteroscopy with stent placement is a common intervention for managing ureteral stones. However, the indwelling stents are prone to encrustation, which can lead to significant complications, including infection, obstruction, and discomfort for patients.
Potassium citrate, an alkalinizing agent, has been shown to prevent uric acid stone formation by raising urinary pH and dissolving existing stones. This trial aims to determine whether potassium citrate can also reduce encrustation on ureteric stents following ureteroscopy for uric acid stones.
In this prospective, randomized, controlled trial, patients undergoing ureteroscopy with stent placement for uric acid stones will be randomly assigned to either the intervention group (receiving potassium citrate) or a control group. The primary outcome is the rate of stent encrustation, which will be assessed using a modified scoring system after stent removal. Secondary outcomes include serum electrolyte levels, adverse events, and changes in urinary pH. All patients will be monitored regularly for changes in urine pH and adverse events during the study.
The findings from this trial may provide valuable insights into the role of potassium citrate in preventing ureteric stent encrustation, ultimately improving patient outcomes and reducing the need for additional interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Experimental Arm)Patients receiving potassium citrate. | Experimental | Drug: Oral Potassium CitrateOral potassium citrate (15 meq twice daily) to maintain urinary pH between 6.8 and 7.2. |
| control arm | No intervention | –No oral potassium citrate or any other treatment for stent encrustation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Oral Potassium CitrateEvaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones | Drug | Intervention Arm (Experimental Arm)Patients receiving potassium citrate. |
Primary outcome
the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system.
Time frame: Stent removal, typically 4-6 weeks after ureteroscopy.
The degree of encrustation on ureteral stents will be assessed using a modified encrustation scoring system upon stent removal. Encrustation severity will be categorized based on deposition on the stent surface, graded from no encrustation to severe encrustation. Stents will be examined macroscopically and, if applicable, under microscopy for calcium and uric acid deposits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral Potassium Citrate in people with Urolithiasis and Stone Ureter, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Feb 2025. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system. (time frame: Stent removal, typically 4-6 weeks after ureteroscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2025.