Risk factors for double-J stent bacterial colonization and its clinical implications
Official title: Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
Run by Al-Azhar University · NCT07740811 · Data updated 2026-11-12
This study looks at which factors make double-J ureteral stents more likely to harbor bacteria and what that means for infections and symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | April 1, 2028 |
| Study ends | May 1, 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07740811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults undergoing temporary double-J ureteral stent placement for standard urological indications who will have the stent removed during follow-up and can provide informed consent.
✕Probably not a fit
Patients with active urosepsis at insertion, long-term stenting plans, or conditions that confound results may have limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational cohort investigates risk factors for bacterial colonization of temporary double-J ureteral stents and how colonization relates to bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms. It compares urine culture results with stent cultures to better understand colonization that urine tests may miss. The study collects cultures at stent insertion and removal and analyzes patient- and device-related factors over the follow-up period. Findings could influence how clinicians interpret cultures and manage empiric therapy for patients with stents. The research is conducted at a Cairo-based center led by Al-Azhar University, with no additional sponsors listed.
Why it matters
Potential benefit: If successful, the study could improve detection of stent colonization and guide more effective antibiotic choices to prevent infections.
How similar studies have gone: Previous research shows that stent cultures can reveal colonization not detected by urine cultures, supporting the importance of direct stent assessment.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Mohamed Fawzy Salman
Cairo, Egypt Recruiting
Study contacts
- Principal investigator: Mohamed Fawzy Salman, MD — Lecturer of urology
- Study coordinator: Mohamed Fawzy Salman, MD
- Email: prof_mohamed_fawzy@yahoo.com
- Phone: 0201111788996
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.