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

Recruiting now

Conditions studied: Urinary Tract Infections, Stent Related Infection

In brief

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.

Key facts

Study ID

NCT05329883

Run by

University Hospital, Ghent

People needed

1000

Starts

2021-11-25

Expected to finish

2025-12-31

Last updated by the study team

2025-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• University Hospital Ghent — Ghent, Eastern-Flanders, Belgium (enrolling)

Full record on ClinicalTrials.gov

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