Clinical trial NCT02845726: Biofilms on Short-term Indwelling Ureteral Stents
Official title: Biofilms on Short-term Indwelling Ureteral Stents: Influence on Associated Symptoms and Complications; Prediction by Urine Analysis; Current Bacterial Spectrum and Antibiotic Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Catheterization
Biofilm
Morbidity
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total biofilm mass on ureteral stents.
timeFrame: Time of stent removal: Four weeks (range 2-6 weeks) after stent insertion
measure: Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Secondary outcomes:
measure: Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.
measure: Urinary analysis (pH, nitrite, leucocyturia, hematuria).
timeFrame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
measure: Urine Culture
timeFrame: Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal)
measure: Rapid immunoassay test for bacteriuria
timeFrame: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
measure: Next generation sequencing of biofilms
timeFrame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
measure: Number of bacteria on stent surface (cell count as estimated by scanning electron microscopy)
timeFrame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
measure: Number of bacteria on stent surface (determined via quantitative PCR)
timeFrame: Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Urological Department, Cantonal Hospital of St. Gallen
state: Saint Gallen
Study officials:
affiliation: Department of Urology
name: Dominik Abt, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.