Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAl-Azhar University
About this trial
This prospective cohort study will evaluate the risk factors associated with bacterial colonization of Double-J ureteral stents and examine its clinical implications. Adult patients undergoing temporary ureteral stent insertion for routine urological indications will be followed until stent removal, when urine and stent cultures will be obtained. The study will assess the association between colonization and factors such as indwelling time, diabetes mellitus, chronic kidney disease, prior urinary tract infection, prior antibiotic exposure, and stent-related symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Temporary Double-J stent insertion.
Standard urological indication.
Planned stent removal during follow-up.
Disqualifiers
Active urosepsis at insertion.
Permanent or intended long-term stenting.
Concomitant nephrostomy tube or urinary diversion.
Severe immunosuppression or neutropenia.
Trial population
Adults with temporary Double-J ureteral stents placed for routine urological indications and available for follow-up until stent removal.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Bacterial colonization of the Double-J ureteral stent
Positive growth on stent culture at removal.
Time frame
At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.Secondary outcomes
1
Positive urine culture
Positive midstream urine culture during stent indwelling or at removal.
Time frame
From stent insertion until stent removal, assessed up to 52 weeks after insertion.2
Number of Participants With Febrile Urinary Tract Infection
Development of urinary tract infection while the stent is in place; Confirmed by Clinical Assessment and Urine Culture
Time frame
From stent insertion until stent removal, assessed up to 52 weeks after insertion.3
Agreement between urine culture and stent culture
Agreement between urine culture and stent culture, assessed by Cohen's kappa coefficient
Time frame
At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.4
Antimicrobial resistance profile
Resistance pattern of organisms isolated from urine and stent cultures.
Time frame
At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.Sponsors and contacts
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Source ClinicalTrials.gov