Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAl-Azhar University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal. At stent 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. If resources permit, biofilm analysis or sonication-based processing may be added to improve detection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Urine and stent cultures
Diagnostic testAll 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
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Patients with fixed JJ stent1 intervention
Trial outcomes
Primary outcomes
1
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
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)
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov