Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial). (MINUS)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    1000
  • sponsor
    University Hospital, Ghent
Updated on 30 April 2022
antibiotics
urine culture
antibiotic prophylaxis
dysuria

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.

Details
Condition Urinary Tract Infections, Stent Related Infection
Treatment Double-J stent removal
Clinical Study IdentifierNCT05329883
SponsorUniversity Hospital, Ghent
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
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