Bacterial Colonization, Double-J Ureteral Stents
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Al-Azhar University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial colonization of the Double-J ureteral stent | At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion. | Positive growth on stent culture at removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive urine culture | From stent insertion until stent removal, assessed up to 52 weeks after insertion. | Positive midstream urine culture during stent indwelling or at removal. |
| Number of Participants With Febrile Urinary Tract Infection | From stent insertion until stent removal, assessed up to 52 weeks after insertion. | Development of urinary tract infection while the stent is in place; Confirmed by Clinical Assessment and Urine Culture |
| Agreement between urine culture and stent culture | At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion. | Agreement between urine culture and stent culture, assessed by Cohen's kappa coefficient |
| Antimicrobial resistance profile | At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion. | Resistance pattern of organisms isolated from urine and stent cultures. |
| Stent-related symptom burden | From stent insertion until stent removal, assessed up to 52 weeks after insertion. | Symptoms such as flank pain, dysuria, hematuria, frequency, and urgency, assessed by questionnaire if available. |
| Hospitalization or additional intervention | From stent insertion until stent removal, assessed up to 52 weeks after insertion. | Need for emergency visit, admission, or additional treatment related to stent-associated complications. |
Countries
Egypt
Contacts
CONTACTAbul-fotouh Ahmed, MD
PRINCIPAL_INVESTIGATORAbul-fotouh Ahmed, MD
Al-Azhar University
Outcome results
None listed