Urinary Tract InfectionsMINUSNCT05329883
Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
An observational study of Urinary Tract Infections and Stent Related Infection, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The MINUS-trial is a multicentric prospective observational study in which consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Stent Related Infection
- What is being tested?
- Double-J stent removal
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Nov 2021to 31 Dec 2025
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate in the study
Who may be able to join
- Patient aged 18 years or above
- Stent placed during endoscopic procedure
- A negative urine culture (UC) pre-operatively with a single dose of antibiotic prophylaxis peri-operatively
- Stent removal is planned in outpatient setting of by the patient by using a string.
- Able and willing to provide consent
Who cannot join
- Permanent indwelling catheter (transurethral catheter, suprapubic catheter, nephrostomy tubes)
- Pregnant patients
- Patient performing clean intermittent (self-)catheterization
- Recent history (<3 months) of demonstrated UTI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, Eastern-Flanders, 9000
Thomas Tailly, MD, +3293322276, thomas.tailly@uzgent.be
About this study
The MINUS-trial is a multicentric prospective observational study in which consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Their stent will be removed in outpatient office or by string extraction at home with or without antibiotic prophylaxis (depending on the standard of care of the participating center). A urine sample will be taken before stent removal and patients will be asked to complete a questionnaire to assess symptoms of urinary tract infection (UTI) after stent removal. If the patient experiences symptoms of UTI (urgency, frequency, dysuria or haematuria) that exceed the usually experienced post-cystoscopy symptoms, they have to provide a urine sample.
The purpose of this study is to provide multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ.
Read more
The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal.
Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.
Read the detailed description
Given the high morbidity, cost and loss of quality of life of stent related infections, there is a need for practical strategies for decreasing stent associated UTI's and sepsis. One of these strategies may be to provide targeted antibiotic prophylaxis. On the other hand, the widespread growing bacterial resistance due to the overuse of antibiotics is of growing concern.
To date, no clear guidelines regarding antibiotic prophylaxis prior to ureteral stent removal are available. The European Association of Urology (EAU) does not recommend antibiotic prophylaxis before cystoscopy, but there is no specific recommendation regarding stent removal. This is mainly due to the lack of good and robust data.
The MINUS-trial is a multicentric prospective observational study with the aim of providing multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ.
The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal.
Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.
All consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Their stent will be removed in outpatient office or by string extraction at home with or without antibiotic prophylaxis (depending on the standard of care of the participating center). A urine sample will be taken before stent removal and patients will be asked to complete a questionnaire to assess symptoms of urinary tract infection (UTI) after stent removal. If the patient experiences symptoms of UTI (urgency, frequency, dysuria or haematuria) that exceed the usually experienced post-cystoscopy symptoms, they have to provide a urine sample.
- Conditions
- Urinary Tract Infections, Stent Related Infection
- Being tested
- Double-J stent removal
- Keywords
- Urinary Tract Infection, Ureteral stent removal, Double-J stent, Ureterorenoscopy, Percutaneous Nephrolithotomy, Endourology
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-J stent removalProcedure or surgery
Outpatient ureteral stent removal without antibiotic prophylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants demonstrating a post-stent removal urinary tract infection
For this outcome measure, a urinary tract infection is defined as a urine sample demonstrating an identified uropathogen with at least 10.000 colony forming units in a patient demonstrating symptoms of a urinary tract infection after removal of a ureteral stent. Asymptomatic bacteriuria will not be considered a positive outcome.
Measured: 30 days after removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start25 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 1,000 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Lucas Gent, Universitaire Ziekenhuizen KU Leuven, General Hospital Groeninge, University of British Columbia, Centre hospitalier de l'Université de Montréal (CHUM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329883
- Sponsor's protocol ID
- BC-10846
- Acronym
- MINUS
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
- ClinicalTrials.gov ID
- NCT05329883
- Acronym / sponsor ID
- MINUS / BC-10846
- Conditions
- Urinary Tract Infections, Stent Related Infection
- Keywords
- Urinary Tract Infection, Ureteral stent removal, Double-J stent, Ureterorenoscopy, Percutaneous Nephrolithotomy, Endourology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- AZ Sint-Lucas Gent, Universitaire Ziekenhuizen KU Leuven, General Hospital Groeninge, University of British Columbia, Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Apr 2022 (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 MINUS-trial is a multicentric prospective observational study in which consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Their stent will be removed in outpatient office or by string extraction at home with or without antibiotic prophylaxis (depending on the standard of care of the participating center). A urine sample will be taken before stent removal and patients will be asked to complete a questionnaire to assess symptoms of urinary tract infection (UTI) after stent removal. If the patient experiences symptoms of UTI (urgency, frequency, dysuria or haematuria) that exceed the usually experienced post-cystoscopy symptoms, they have to provide a urine sample.
The purpose of this study is to provide multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ.
The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal.
Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.
Detailed description
Given the high morbidity, cost and loss of quality of life of stent related infections, there is a need for practical strategies for decreasing stent associated UTI's and sepsis. One of these strategies may be to provide targeted antibiotic prophylaxis. On the other hand, the widespread growing bacterial resistance due to the overuse of antibiotics is of growing concern.
To date, no clear guidelines regarding antibiotic prophylaxis prior to ureteral stent removal are available. The European Association of Urology (EAU) does not recommend antibiotic prophylaxis before cystoscopy, but there is no specific recommendation regarding stent removal. This is mainly due to the lack of good and robust data.
The MINUS-trial is a multicentric prospective observational study with the aim of providing multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ.
The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal.
Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.
All consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Their stent will be removed in outpatient office or by string extraction at home with or without antibiotic prophylaxis (depending on the standard of care of the participating center). A urine sample will be taken before stent removal and patients will be asked to complete a questionnaire to assess symptoms of urinary tract infection (UTI) after stent removal. If the patient experiences symptoms of UTI (urgency, frequency, dysuria or haematuria) that exceed the usually experienced post-cystoscopy symptoms, they have to provide a urine sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate in the study
Key inclusion criteria (5 listed)
- Patient aged 18 years or above
- Stent placed during endoscopic procedure
- A negative urine culture (UC) pre-operatively with a single dose of antibiotic prophylaxis peri-operatively
- Stent removal is planned in outpatient setting of by the patient by using a string.
- Able and willing to provide consent
Key exclusion criteria (4 listed)
- Permanent indwelling catheter (transurethral catheter, suprapubic catheter, nephrostomy tubes)
- Pregnant patients
- Patient performing clean intermittent (self-)catheterization
- Recent history (<3 months) of demonstrated UTI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-J stent removalOutpatient ureteral stent removal without antibiotic prophylaxis | Procedure or surgery | – |
Primary outcome
number of participants demonstrating a post-stent removal urinary tract infection
Time frame: 30 days after removal
For this outcome measure, a urinary tract infection is defined as a urine sample demonstrating an identified uropathogen with at least 10.000 colony forming units in a patient demonstrating symptoms of a urinary tract infection after removal of a ureteral stent. Asymptomatic bacteriuria will not be considered a positive outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 Urinary Tract Infections and Stent Related Infection, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants demonstrating a post-stent removal urinary tract infection (time frame: 30 days after removal). 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 15 Jan 2025.