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
Efficacy of Oral Potassium Citrate in Reducing Ureteral Stent Encrustation Post-Ureteroscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Ash Sharqiyah
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Zagazig, Ash Sharqiyah, Egypt, 44511
- Faculty of Medicine - Zagazig University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm (Experimental Arm)Patients receiving potassium citrate.
Oral potassium citrate (15 meq twice daily) to maintain urinary pH between 6.8 and 7.2.
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Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones
|
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No Intervention: control arm
No oral potassium citrate or any other treatment for stent encrustation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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. |
Stent removal, typically 4-6 weeks after ureteroscopy.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 571/13-Aug-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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