Assessment of Longterm Ureteral Stenting

January 30, 2019 updated by: Patrick Betschart, Cantonal Hospital of St. Gallen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland
        • Urological Department, Cantonal Hospital of St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with longterm indwelling ureteral stent undergoing regular changes in an inpatient or outpatient setting at the department of urology of KSSG.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with longterm ureteral stent
Other: Stent examination, urinary analysis, USSQ questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total biofilm mass on ureteral stents
Time Frame: Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change
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)
Time Frame: Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Patrick Betschart, Dr. med., Department of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTU 16.011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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