Biofilms on Short-term Indwelling Ureteral Stents

Completed

• Conditions: Ureteral Catheterization; Biofilm; Morbidity
• Interventions: Other: Stent examination, urinary analysis, USSQ questionnaire

• Registration Number: NCT02845726
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-23
• Study First Posted: 2016-07-27
• Primary Completion: 2017-09-23
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with temporary ureteral stent	Stent examination, urinary analysis, USSQ questionnaire	Assessment of patients transiently undergoing ureteral stenting.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Urinary analysis (pH, nitrite, leucocyturia, hematuria).	Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Next generation sequencing of biofilms	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.
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
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)

Trial Locations

Locations (1)

Urological Department, Cantonal Hospital of St. Gallen; 🇨🇭 St. Gallen, Saint Gallen, Switzerland