Biofilms on Short-term Indwelling Ureteral Stents

Cantonal Hospital of St. Gallen85 enrolled

Overview

This study is performed to analyze various aspects of biofilms on ureteral stents.

The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity. Moreover, it could provide more detailed knowledge about the correlation of the occurrence of biofilms on ureteral stents and findings in urinary analysis, which could serve as a decision support whether patients with ureteral stents undergoing further interventions (for example ESWL or simple secondary URS) should receive antibiotic prophylaxis. Correlation of results of urinary bacteriologies (assessed pre- and intraoperatively) and biofilm analysis on stents could provide information if "targeted antibiotic treatment" based on urinary bacteriology only is possible at all. Correlation of urinary analysis and conventional urinary bacteriology could provide a valuable contribution regarding the prediction of bacteriuria and the necessity of postponing operations. Additionally, the study is intended to provide an overview over the recent bacterial species that are involved into biofilms on ureteral stents and their resistance to antibiotics. This could provide valuable information about the choice of antibiotics in cases were treatment has to be performed empirically.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ureteral Catheterization Biofilm Morbidity

Interventions

Stent examination, urinary analysis, USSQ questionnaireOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients temporarily undergoing ureteral stenting * Informed consent Exclusion Criteria: * Bilateral stenting * Ureteral obstruction due to malignancies * Additionally performed procedures/operations during stent indwelling time -Cognitively impaired patients * UTI at the time of stent insertion (\>10 to the power of 2 cfu/ml)

Locations (1)

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Outcomes

Primary Outcomes

Total biofilm mass on ureteral stents.

Time frame: Time of stent removal: Four weeks (range 2-6 weeks) after stent insertion

Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)

Time frame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)

Secondary Outcomes

Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)

Time frame: One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.

Urinary analysis (pH, nitrite, leucocyturia, hematuria).

Time frame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)

Urine Culture

Time frame: Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal)

Rapid immunoassay test for bacteriuria

Time frame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)

Next generation sequencing of biofilms

To identify bacterial species that are involved into biofilms on ureteral stents.

Time frame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion

Number of bacteria on stent surface (cell count as estimated by scanning electron microscopy)

Time frame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion

Number of bacteria on stent surface (determined via quantitative PCR)

Data from ClinicalTrials.gov

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