NCT03869580

Brief Summary

The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 4, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 11, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

March 4, 2019

Last Update Submit

March 8, 2019

Conditions

Double J Stent

Outcome Measures

Primary Outcomes (2)

  • Number of patients with urinary tract infection associated with double J stent

    Number of patients with urinary tract infection associated with double J stent

    6 months

  • Number of patients with specific clinical data associated with urinary tract infection associated with double J stent

    Clinical data (Age, sex, gender, comorbidities, indication of procedure, duration of double J stent placement) will be compared between patient with urinary tract infection and no urinary tract infection associated with double J stent

    6 months

Secondary Outcomes (1)

  • Number of patients with relapse and/or recurrence after a first urinary tract infection

    6 months

Study Arms (2)

Stent infection

Patients diagnosed with urinary tract infection associated with double J stent

No stent infection

Patients with double J stent without infection during the study period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with a double-J stent placement or change in the hospital will be included. Follow-up will be repeated at 1, 3 and 6 months and urinary tract infection will be reported

You may qualify if:

  • Patients with a double-J stent placement or change in the hospital

You may not qualify if:

  • renal transplants less than one year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 11, 2019

Study Start

April 1, 2019

Primary Completion

April 1, 2021

Study Completion

December 1, 2021

Last Updated

March 11, 2019

Record last verified: 2019-02

Locations

FR(1)