Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization

Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Colonization; Double-J Ureteral Stents

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Abul-fotouh Ahmed, MD; Phone Number: 00201001066756; Email: abulfotouhahmed@yahoo.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11633
      • Recruiting
      • Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
      • Contact: Abul-fotouh Ahmed, MD; Phone Number: +201001066756; Email: abulfotouhahmed@yahoo.com
      • Sub-Investigator: Mahmoud M Abdelmalik
      • Sub-Investigator: Ahmed AlRefae, MD
      • Sub-Investigator: Ibrahim Tagreda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adults with temporary Double-J ureteral stents placed for routine urological indications and available for follow-up until stent removal.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial colonization of the Double-J ureteral stent	Positive growth on stent culture at removal.	At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive urine culture	Positive midstream urine culture during stent indwelling or at removal.	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	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	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.	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.	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.	From stent insertion until stent removal, assessed up to 52 weeks after insertion.

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Abul-fotouh Ahmed, MD, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UroAzhar_9_026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No