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Clinical Trials/NCT02845726
NCT02845726
Completed
Not Applicable

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

Cantonal Hospital of St. Gallen1 site in 1 country85 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ureteral Catheterization
Sponsor
Cantonal Hospital of St. Gallen
Enrollment
85
Locations
1
Primary Endpoint
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dominik Abt

Dr. med.

Cantonal Hospital of St. Gallen

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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)

Total biofilm mass on ureteral stents.

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

Secondary Outcomes

  • Urinary analysis (pH, nitrite, leucocyturia, hematuria).(Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion))
  • 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)
  • Next generation sequencing of biofilms(Day of stent removal: Four weeks (range 2-6 weeks) after stent 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.)
  • Rapid immunoassay test for bacteriuria(Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion))
  • Number of bacteria on stent surface (determined via quantitative PCR)(Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion)
  • Urine Culture(Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal))

Study Sites (1)

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