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

NCT06819553 | Active Not Recruiting Phase 2

• 1 other identifier: 571/13-Aug-2024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Stone Ureter

Keywords

stone disease; Oral Potassium Citrate

Outcome Measures

Primary Outcomes (1)

• 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.

  Stent removal, typically 4-6 weeks after ureteroscopy.

Study Arms (2)

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.

Drug: Oral Potassium Citrate

control arm

NO INTERVENTION

No oral potassium citrate or any other treatment for stent encrustation

Interventions

Oral Potassium Citrate DRUG

Evaluate the Effectiveness of Oral Potassium Citrate in Preventing Ureteral Stent Encrustation in Patients Undergoing Ureteroscopy for Uric Acid Kidney Stones

Intervention Arm (Experimental Arm)Patients receiving potassium citrate.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of medicine - Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

MeSH Terms

Conditions

Urolithiasis; Ureterolithiasis

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ureteral Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: November 3, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2024-08

Locations

EG (1)