Assessment of Longterm Ureteral Stenting

Longterm Indwelling Ureteral Stent Clinical Trial

Official title:

Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871609
• Other study ID #: CTU 16.011
• Status: Completed
• Start date: July 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• 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 in a longterm setting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Longterm Indwelling Ureteral Stent

Intervention

Other:
• Stent examination, urinary analysis, USSQ questionnaire

Locations

Country	Name	City	State
Switzerland	Urological Department, Cantonal Hospital of St. Gallen	St. 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/change: three months (range 2-4 months) after last stent insertion/change
Primary	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	Urine Culture		2-6 months after stent insertion
Secondary	Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents		2-6 months after stent insertion
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		2-6 months after stent insertion
Secondary	Assessment of costs arising from complications	complications assessed by CTCAE v4.0	2-6 months after stent insertion