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

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

Study Overview

• Status: Completed
• Conditions: Morbidity; Ureteral Catheterization; Biofilm
• Intervention / Treatment: Other: Stent examination, urinary analysis, USSQ questionnaire

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.

• Study Type: Observational
• Enrollment (Anticipated): 85

Contacts and Locations

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Urological Department, Cantonal Hospital of St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ureteral stenting for the preparation of a secondary intervention in an inpatient setting at the department of urology of KSSG.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with temporary ureteral stent; Assessment of patients transiently undergoing ureteral stenting.	Other: Stent examination, urinary analysis, USSQ questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)		One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.
Urinary analysis (pH, nitrite, leucocyturia, hematuria).		Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Urine Culture		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		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.	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)		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

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Dominik Abt, Dr. med., Department of Urology

Publications and helpful links

General Publications

• Buhmann MT, Abt D, Nolte O, Neu TR, Strempel S, Albrich WC, Betschart P, Zumstein V, Neels A, Maniura-Weber K, Ren Q. Encrustations on ureteral stents from patients without urinary tract infection reveal distinct urotypes and a low bacterial load. Microbiome. 2019 Apr 13;7(1):60. doi: 10.1186/s40168-019-0674-x.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): September 23, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 23, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CTU 15.010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No