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NCT Number: NCT07760792

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Bacterial colonization of the Double-J ureteral stent

    Time frame: 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 outcomes

  1. Positive urine culture

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

    Positive midstream urine culture during stent indwelling or at removal.

  2. Number of Participants With Febrile Urinary Tract Infection

    Time frame: 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

  3. Agreement between urine culture and stent culture

    Time frame: 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

  4. Antimicrobial resistance profile

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

    Resistance pattern of organisms isolated from urine and stent cultures.

  5. Stent-related symptom burden

    Time frame: 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.

  6. Hospitalization or additional intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abul-fotouh Ahmed

CONTACT

[email protected]

00201001066756

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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