Biofilms on Short-term Indwelling Ureteral Stents
1 other identifier
observational
85
1 country
1
Brief Summary
This study is performed to analyze various aspects of biofilms on ureteral stents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 25, 2018
January 1, 2018
1.2 years
July 8, 2016
January 24, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
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
Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion
- +2 more secondary outcomes
Study Arms (1)
Patients with temporary ureteral stent
Assessment of patients transiently undergoing ureteral stenting.
Interventions
Eligibility Criteria
Patients undergoing ureteral stenting for the preparation of a secondary intervention in an inpatient setting at the department of urology of KSSG.
You may qualify if:
- Patients temporarily undergoing ureteral stenting
- Informed consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urological Department, Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Related Publications (1)
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.
PMID: 30981280DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Dominik Abt, Dr. med.
Department of Urology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 27, 2016
Study Start
July 1, 2016
Primary Completion
September 23, 2017
Study Completion
December 1, 2017
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share