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.