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

NCT07760792 | Not Yet Recruiting

• 1 other identifier: UroAzhar_9_026
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Colonization; Double-J Ureteral Stents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Positive urine culture

  From stent insertion until stent removal, assessed up to 52 weeks after insertion.

• Number of Participants With Febrile Urinary Tract Infection

  From stent insertion until stent removal, assessed up to 52 weeks after insertion.

• Agreement between urine culture and stent culture

  At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.

• Antimicrobial resistance profile

  At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.

• Stent-related symptom burden

  From stent insertion until stent removal, assessed up to 52 weeks after insertion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Officials

• Abul-fotouh Ahmed, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abul-fotouh Ahmed

CONTACT

00201001066756; abulfotouhahmed7070@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 12, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-07