Biofilms on Short-term Indwelling Ureteral Stents

NCT ID: NCT02845726

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

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.

Conditions

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Ureteral Catheterization Biofilm Morbidity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with temporary ureteral stent

Assessment of patients transiently undergoing ureteral stenting.

Stent examination, urinary analysis, USSQ questionnaire

Intervention Type OTHER

Interventions

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Stent examination, urinary analysis, USSQ questionnaire

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Dominik Abt

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominik Abt, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Urology

Locations

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Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 30981280 (View on PubMed)

Other Identifiers

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CTU 15.010

Identifier Type: -

Identifier Source: org_study_id

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