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

28. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

400

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

      • Cairo, Ägypten
        • Rekrutierung
        • Mohamed Fawzy Salman
        • Kontakt:
          • Mohamed Fawzy Salman, MD
          • Telefonnummer: 01111788996
        • Kontakt:
        • Hauptermittler:
          • salman, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

N/A

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Mohamed Fawzy Salman, MD, Lecturer of urology

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. April 2026

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

1. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

28. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • Stent Bacterial Colonization

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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