Biofilms on Short-term Indwelling Ureteral Stents

Study Overview
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Brief Summary
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This study is performed to analyze various aspects of biofilms on ureteral stents.

Detailed Description
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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.

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

Conditions
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Ureteral Catheterization, Biofilm, Morbidity

Intervention / Treatment
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* Other: Stent examination, urinary analysis, USSQ questionnaire


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with temporary ureteral stent<br>Assessment of patients transiently undergoing ureteral stenting. | Other: Stent examination, urinary analysis, USSQ questionnaire<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |