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Completed

NCT Number: NCT02845726

Biofilms on Short-term Indwelling Ureteral Stents

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

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Key information

Conditions

Ureteral Catheterization Biofilm Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stent examination, urinary analysis, USSQ questionnaire

Other

Primary outcomes

  1. Total biofilm mass on ureteral stents.

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

  2. 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

  1. 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.

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

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

  3. 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)

  4. Rapid immunoassay test for bacteriuria

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

  5. Next generation sequencing of biofilms

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

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

  6. 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

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

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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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