An observational study in Bacterial Colonization and Double-J Ureteral Stents, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Al-Azhar University · Observational
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.
This prospective observational cohort study will enroll adult patients undergoing temporary Double-J ureteral stent insertion at Al-Azhar University hospitals in Cairo, Egypt. Participants will be followed from stent insertion until removal. Baseline demographic, clinical, and laboratory data will be collected, together with stent-related variables such as stent side, size, material, and indwelling time. Midstream urine culture will be obtained when feasible before insertion and again at removal, and the stent will be cultured under sterile conditions at removal.
The primary outcome is bacterial colonization of the Double-J stent, defined as positive growth on stent culture at removal. Secondary outcomes include positive urine culture, febrile urinary tract infection, concordance between urine and stent cultures, antimicrobial resistance patterns, stent-related symptom burden, and need for hospitalization or additional treatment. Risk factors for colonization will be analyzed using multivariable logistic regression.
Adults with temporary Double-J ureteral stents placed for routine urological indications and available for follow-up until stent removal.
Exclusion Criteria:
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.
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.
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.
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.
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.
Stent-related symptom burden
Symptoms such as flank pain, dysuria, hematuria, frequency, and urgency, assessed by questionnaire if available.
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Hospitalization or additional intervention
Need for emergency visit, admission, or additional treatment related to stent-associated complications.
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
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Al-Azhar University