Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Study Overview
Brief 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.
Detailed Description
Ureteral stents are indispensable in modern urology, but they are frequently complicated by bacterial colonization, biofilm formation, bacteriuria, and infectious morbidity.
Biofilm is clinically important because it promotes microbial persistence on the stent surface, reduces antimicrobial susceptibility, and may contribute to urinary tract infection (UTI) or even severe systemic infection in selected patients.
Prospective studies have shown that febrile ureteral stent-associated UTI occurs in a measurable proportion of patients and can progress to sepsis or septic shock in a subset.
More recent studies also confirm that colonization and resistance patterns vary by patient profile and stent dwell time.A major challenge in this field is that urine culture does not reliably exclude stent colonization.
Several studies have shown that a substantial proportion of patients with sterile urine still have colonized stents, meaning that urine testing alone may underestimate the burden of device-associated infection. In addition, the organisms recovered from stents are often more resistant than those isolated before stent insertion, which raises concern about delayed recognition and suboptimal empiric antibiotic choice in high-risk patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Fawzy Abd Elfattah Salman
Lecturer of Urology
Al-Azhar University