NCT02871609

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

August 5, 2016

Last Update Submit

January 30, 2019

Conditions

Longterm Indwelling Ureteral Stent

Keywords

BiofilmMorbidityUreteral Catheterization

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Patients with longterm ureteral stent

Other: Stent examination, urinary analysis, USSQ questionnaire

Interventions

Stent examination, urinary analysis, USSQ questionnaireOTHER
Patients with longterm ureteral stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Switzerland

Location

Study Officials

  • Patrick Betschart, Dr. med.

    Department of Urology

    PRINCIPAL INVESTIGATOR

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

August 5, 2016

First Posted

August 18, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)