Clinical Trial

Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.

Not Yet Recruiting Phase 4
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Record status
This record was last updated December 24, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Indwelling Double J (DJ) ureteral stents are commonly used following lithotripsy to ensure adequate urinary drainage and prevent obstruction. However, stent-related biofilm formation remains a significant clinical problem, contributing to infection, encrustation, patient discomfort, and stent failure. Biofilms consist of microbial communities embedded within an extracellular polymeric substance (EPS), which protects microorganisms from host defenses and antimicrobial agents. Antibiotic therapy alone may be insufficient to eradicate established biofilms due to poor penetration into the EPS matrix. Linezolid is a potent antibiotic with activity against gram-positive organisms commonly implicated in urinary tract colonization and penetrate and effectively act against bacterial biofilms. Mucolytic agents, by disrupting the biofilm matrix, may enhance antimicrobial penetration and reduce biofilm burden. The combination of an antibiotic with a mucolytic agent may therefore provide superior biofilm reduction compared to either approach alone or no treatment.
Trial Details
NCT Number NCT07301294
Lead Sponsor Menoufia University
Conditions Double J Stent
Enrollment 100 participants
Start Date 2026-01-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-24