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Biofilms on Short-term Indwelling Ureteral Stents

Biofilms on Short-term Indwelling Ureteral Stents: Influence on Associated Symptoms and Complications; Prediction by Urine Analysis; Current Bacterial Spectrum and Antibiotic Resistance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02845726
Enrollment
85
Registered
2016-07-27
Start date
2016-07-31
Completion date
2017-12-31
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biofilm, Morbidity, Ureteral Catheterization

Brief summary

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

Detailed description

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.

Interventions

Sponsors

Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Total biofilm mass on ureteral stents.Time of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)

Secondary

MeasureTime frameDescription
Urine CultureBefore study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal)
Rapid immunoassay test for bacteriuriaDay before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.
Number of bacteria on stent surface (cell count as estimated by scanning electron microscopy)Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Number of bacteria on stent surface (determined via quantitative PCR)Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Next generation sequencing of biofilmsDay of stent removal: Four weeks (range 2-6 weeks) after stent insertionTo identify bacterial species that are involved into biofilms on ureteral stents.
Urinary analysis (pH, nitrite, leucocyturia, hematuria).Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026