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

28 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

400

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Cairo, Egitto
        • Reclutamento
        • Mohamed Fawzy Salman
        • Contatto:
          • Mohamed Fawzy Salman, MD
          • Numero di telefono: 01111788996
        • Contatto:
        • Investigatore principale:
          • salman, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mohamed Fawzy Salman, MD, Lecturer of urology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

1 aprile 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

28 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 luglio 2026

Primo Inserito (Effettivo)

3 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Stent Bacterial Colonization

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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