Risk factors for bacterial growth on double-J ureteral stents
Official title: Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
Run by Al-Azhar University · NCT07760792 · Data updated 2026-11-12
This observational study tests which factors are linked to bacterial colonization of temporary double-J ureteral stents in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | August 10, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | July 30, 2027 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07760792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with planned temporary double-J stent insertion for standard urological indications.
✕Probably not a fit
Patients without risk factors for infection or with short anticipated indwelling times may have little chance of benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective cohort, adults receiving temporary double-J ureteral stents at Al-Azhar University hospitals will be followed from insertion to stent removal. Researchers will collect demographics, clinical data, and stent details, and will culture urine and the stent to identify bacterial colonization. The study will analyze associations between colonization and factors such as indwelling time, diabetes, kidney disease, prior UTIs, prior antibiotics, and stent symptoms, using multivariable logistic regression. Primary outcome is stent colonization at removal; secondary outcomes include urine culture results, febrile UTIs, antimicrobial resistance, symptom burden, and need for hospitalization or treatment changes.
Why it matters
Potential benefit: If successful, the study could help clinicians identify patients at higher risk of stent colonization and inform strategies to minimize infection and related complications.
How similar studies have gone: Other studies have explored urinary tract infections and stent colonization, but this study provides a targeted look at risk factors and local antimicrobial patterns in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Temporary Double-J stent insertion. * Standard urological indication. * Planned stent removal during follow-up. * Ability to attend follow-up and provide specimens. * Written informed consent. Exclusion Criteria: * Active urosepsis at insertion. * Permanent or intended long-term stenting. * Concomitant nephrostomy tube or urinary diversion. * Severe immunosuppression or neutropenia. * Incomplete baseline data. * Loss to follow-up or failure to retrieve the stent. * Refusal to participate.
Where it's running
-
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Abul-fotouh Ahmed, MD — Al-Azhar University
- Study coordinator: Abul-fotouh Ahmed, MD
- Email: abulfotouhahmed@yahoo.com
- Phone: 00201001066756
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Risk factors for double-J stent bacterial colonization and its clinical implications
This study looks at which factors make double-J ureteral stents more likely to harbor bacteria and what that means for infections and symptoms.
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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.