Clinical trial NCT05329883: Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
Official title: Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infections
Stent Related Infection
Keywords: Urinary Tract Infection
Ureteral stent removal
Double-J stent
Ureterorenoscopy
Percutaneous Nephrolithotomy
Endourology
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: AZ Sint-Lucas Gent
name: Universitaire Ziekenhuizen KU Leuven
name: General Hospital Groeninge
name: University of British Columbia
name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2022-04-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Permanent indwelling catheter (transurethral catheter, suprapubic catheter, nephrostomy tubes)
* Pregnant patients
* Patient performing clean intermittent (self-)catheterization
* Recent history (\<3 months) of demonstrated UTI

Primary outcomes:
measure: number of participants demonstrating a post-stent removal urinary tract infection
timeFrame: 30 days after removal
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Ghent
state: Eastern-Flanders
Study officials:
References: