Actively Recruiting

Age: 18Years +
All Genders
NCT05329883

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

Led by University Hospital, Ghent · Updated on 2025-01-15

1000

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

A

AZ Sint-Lucas Gent

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 years or above
  • Stent placed during endoscopic procedure
  • Negative urine culture before procedure with single dose antibiotic given around procedure time
  • Stent removal planned in outpatient setting or by patient using a string
  • Able and willing to provide consent
Not Eligible

You will not qualify if you...

  • Permanent indwelling urinary catheter or nephrostomy tubes
  • Pregnant patients
  • Patients performing clean intermittent self-catheterization
  • Recent urinary tract infection within the past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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3
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Trial Site Locations

Total: 1 location

1

University Hospital Ghent

Ghent, Eastern-Flanders, Belgium, 9000

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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