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

Phase 2

Active, not recruiting

• Conditions: Urolithiasis; Stone Ureter
• Interventions: Drug: Oral Potassium Citrate

• Registration Number: NCT06819553
• Lead Sponsor: Zagazig University

Brief 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. 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 Timeline

• Status Verified: 2024-08
• Study Start: 2024-11-03
• Primary Completion: 2025-02-01
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm (Experimental Arm)Patients receiving potassium citrate.	Oral Potassium Citrate	Oral potassium citrate (15 meq twice daily) to maintain urinary pH between 6.8 and 7.2.

Primary Outcome Measures

Name	Time	Method
the rate of encrustation on the ureteral stents, which will be assessed after stent removal using a modified scoring system.	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.

Trial Locations

Locations (1)

faculty of medicine - Zagazig University; 🇪🇬 Zagazig, Ash Sharqiyah, Egypt