Double J StentIJJNCT03869580
Incidence and Factors Associated With Double-J Urinary Stent Infection (IJJ)
An observational study of Double J Stent, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double J Stent
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with a double-J stent placement or change in the hospital
Who cannot join
- renal transplants less than one year old
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection.
- Conditions
- Double J Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with urinary tract infection associated with double J stent
Number of patients with urinary tract infection associated with double J stent
Measured: 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
Measured: 6 months
Secondary outcomes (1)
Number of patients with relapse and/or recurrence after a first urinary tract infection
Number of patients with relapse and/or recurrence after a first urinary tract infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double J StentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869580
- Sponsor's protocol ID
- P/2018/396
- Acronym
- IJJ
- Status last verified
- Feb 2019
- First submitted
- 4 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Factors Associated With Double-J Urinary Stent Infection (IJJ)
- ClinicalTrials.gov ID
- NCT03869580
- Acronym / sponsor ID
- IJJ / P/2018/396
- Conditions
- Double J Stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with a double-J stent placement or change in the hospital
Key exclusion criteria (1 listed)
- renal transplants less than one year old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with urinary tract infection associated with double J stent
Time frame: 6 months
Number of patients with urinary tract infection associated with double J stent
Number of patients with specific clinical data associated with urinary tract infection associated with double J stent
Time frame: 6 months
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
1 secondary outcome
Number of patients with relapse and/or recurrence after a first urinary tract infection
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Double J Stent, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with urinary tract infection associated with double J stent (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.