Biofilms on Short-term Indwelling Ureteral Stents

Morbidity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845726
• Other study ID #: CTU 15.010
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: January 24, 2018
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is performed to analyze various aspects of biofilms on ureteral stents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2017
• Est. primary completion date: September 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Biofilm
• Morbidity
• Ureteral Catheterization

Intervention

Other:
• Stent examination, urinary analysis, USSQ questionnaire

Locations

Country	Name	City	State
Switzerland	Urological Department, Cantonal Hospital of St. Gallen	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total biofilm mass on ureteral stents.		Time of stent removal: Four weeks (range 2-6 weeks) after stent insertion
Primary	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	Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)		One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.
Secondary	Urinary analysis (pH, nitrite, leucocyturia, hematuria).		Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Secondary	Urine Culture		Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal)
Secondary	Rapid immunoassay test for bacteriuria		Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Secondary	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
Secondary	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
Secondary	Number of bacteria on stent surface (determined via quantitative PCR)		Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion