Assessment of Longterm Ureteral Stenting

Completed

• Conditions: Longterm Indwelling Ureteral Stent
• Interventions: Other: Stent examination, urinary analysis, USSQ questionnaire

• Registration Number: NCT02871609
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.

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 in a longterm setting.

In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects.

The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes
• Informed consent
• responsible patients

Exclusion Criteria

• ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome
• insufficient language skills
• cognitive limitation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with longterm ureteral stent	Stent examination, urinary analysis, USSQ questionnaire	-

Primary Outcome Measures

Name	Time	Method
Total biofilm mass on ureteral stents	Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)	Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change

Secondary Outcome Measures

Name	Time	Method
Urine Culture	2-6 months after stent insertion
Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents	2-6 months after stent insertion
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	2-6 months after stent insertion
Assessment of costs arising from complications	2-6 months after stent insertion	complications assessed by CTCAE v4.0

Trial Locations

Locations (1)

Urological Department, Cantonal Hospital of St. Gallen; 🇨🇭 St. Gallen, Switzerland