Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

28 juillet 2026 mis à jour par: Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.

Aperçu de l'étude

Statut

Recrutement

Description détaillée

Ureteral stents are indispensable in modern urology, but they are frequently complicated by bacterial colonization, biofilm formation, bacteriuria, and infectious morbidity.

Biofilm is clinically important because it promotes microbial persistence on the stent surface, reduces antimicrobial susceptibility, and may contribute to urinary tract infection (UTI) or even severe systemic infection in selected patients.

Prospective studies have shown that febrile ureteral stent-associated UTI occurs in a measurable proportion of patients and can progress to sepsis or septic shock in a subset.

More recent studies also confirm that colonization and resistance patterns vary by patient profile and stent dwell time.A major challenge in this field is that urine culture does not reliably exclude stent colonization.

Several studies have shown that a substantial proportion of patients with sterile urine still have colonized stents, meaning that urine testing alone may underestimate the burden of device-associated infection. In addition, the organisms recovered from stents are often more resistant than those isolated before stent insertion, which raises concern about delayed recognition and suboptimal empiric antibiotic choice in high-risk patients.

These findings support the need to study stent cultures and patient factors together rather than relying on urine culture alone.

The risk factors for bacterial colonization appear to be multifactorial, but the most consistently reported predictor is longer indwelling time. Other factors that have emerged across studies include diabetes mellitus, chronic kidney disease, pregnancy, prior urinary infection, prior catheterization, and albuminuria, although the strength of association is not uniform across all cohorts. Despite this, there is still limited prospective evidence integrating these predictors with clinical outcomes such as febrile UTI, symptom burden, and antimicrobial resistance.

Accordingly, we hypothesize that bacterial colonization of Double-J ureteral stents is associated with identifiable patient- and stent-related risk factors, especially prolonged indwelling time and metabolic or renal comorbidity, and that colonized stents are associated with clinically meaningful outcomes including bacteriuria, resistant organisms, and greater stent-related morbidity.

The significance of this study is that it may help refine patient counseling, improve timing of stent removal, and support targeted surveillance and antibiotic strategies in high-risk patients.

AIM OF THE STUDY To identify the risk factors associated with bacterial colonization of Double-J ureteral stents and to evaluate its clinical implications, including bacteriuria, UTI, antimicrobial resistance, and stent-related symptoms.

Type d'étude

Observationnel

Inscription (Estimé)

400

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Cairo, Egypte
        • Recrutement
        • Mohamed Fawzy Salman
        • Contact:
          • Mohamed Fawzy Salman, MD
          • Numéro de téléphone: 01111788996
        • Contact:
        • Chercheur principal:
          • salman, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

N/A

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal.

At stent removal, the stent will be handled under sterile conditions and sent for culture.

If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments.

Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing.

The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status.

If resources permit, biofilm analysis or sonication-based processing may be added to improve detection

La description

Inclusion Criteria:

  • Patients undergoing temporary Double-J ureteral stent insertion.
  • Stent inserted for a standard urological indication, including ureteric stone disease, ureteral obstruction, postoperative drainage, or ureteral injury repair.
  • Planned stent removal during the study follow-up period.
  • Availability for clinical follow-up and specimen collection at insertion and removal.
  • Provision of written informed consent.

Exclusion Criteria:

  • Active urosepsis at the time of stent insertion.
  • Permanent or intended long-term stenting outside the study framework.
  • Concomitant nephrostomy tube or urinary diversion that may confound microbiological results.
  • Known severe immunosuppression or neutropenia if expected to substantially alter colonization risk.
  • Patients with incomplete baseline clinical data.
  • Patients lost to follow-up or whose stent could not be retrieved for microbiological analysis.
  • Refusal to participate.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients with fixed JJ stent

All adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility.

Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal

All adult patients who undergo Double-J ureteral stent insertion for standard urological indications during the study period will be assessed for eligibility.

Patients will be followed until stent removal, and microbiological evaluation will be performed on both urine and stent specimens at the time of removal

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Délai: 2 weeks

A midstream urine sample will be obtained before stent insertion whenever feasible and again at the time of stent removal.

At removal, the stent will be handled under sterile conditions and sent for culture. If possible, the proximal and distal stent segments will be cultured separately to assess concordance between device segments.

Standard microbiological methods will be used to identify organisms and perform antimicrobial susceptibility testing.

The main endpoint of microbiological assessment will be bacterial colonization of the stent, defined as significant growth from the stent culture regardless of urine culture status.

patients will be classified as positive (if bacterial growth detected) or negative (if the culture was sterile)

2 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Mohamed Fawzy Salman, MD, Lecturer of urology

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 avril 2026

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

1 mai 2028

Dates d'inscription aux études

Première soumission

28 juillet 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Stent Bacterial Colonization

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner