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

28 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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 de estudio

De observación

Inscripción (Estimado)

400

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Cairo, Egipto
        • Reclutamiento
        • Mohamed Fawzy Salman
        • Contacto:
          • Mohamed Fawzy Salman, MD
          • Número de teléfono: 01111788996
        • Contacto:
        • Investigador principal:
          • salman, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Bacterial colonization of the Double-J ureteral stent, defined as positive growth on stent culture at removal.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2026

Finalización primaria (Estimado)

1 de abril de 2028

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2026

Publicado por primera vez (Actual)

3 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Stent Bacterial Colonization

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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