Ireland
--:--IST
Recruiting Observational

Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study

NCT07740811 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2026-04-01
Last updated
2026-08-03

Condition(s) studied

UTIBacterial Colonization

Investigational drug(s) / intervention(s)

Urine and stent cultures

Urine and stent cultures: All adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility. Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal

Study summary

To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing temporary Double-J ureteral stent insertion. * Stent inserted for a standard urological indication, including ureteric stone disease, ureteral obstruction, postoperative drainage, or ureteral injury repair. * Planned stent removal during the study follow-up period. * Availability for clinical follow-up and specimen collection at insertion and removal. * Provision of written informed consent. Exclusion Criteria: * Active urosepsis at the time of stent insertion. * Permanent or intended long-term stenting outside the study framework. * Concomitant nephrostomy tube or urinary diversion that may confound microbiological results. * Known severe immunosuppression or neutropenia if expected to substantially alter colonization risk. * Patients with incomplete baseline clinical data. * Patients lost to follow-up or whose stent could not be retrieved for microbiological analysis. * Refusal to participate.

Primary outcome measure(s)

  • Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal. — 2 weeks
    A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal. At removal, the stent will be handled under sterile conditions and sent for culture. If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments. Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing. The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status. patients will be classified as positive (if bacterial growth detected) or negative (if the culture was sterile)

Trial sites (1)

FacilityCityRegionStatus
Mohamed Fawzy Salman Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07740811 on ClinicalTrials.gov ↗ ← All trials in Egypt