Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05329883 |
| Other study ID # |
BC-10846 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2021 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
University Hospital, Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
