NCT05329883 Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
| NCT ID | NCT05329883 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Urinary Tract Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-11-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-11-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05329883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05329883 currently recruiting?
Yes, NCT05329883 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Ghent to inquire about joining.
Where is the NCT05329883 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT05329883 clinical trial?
NCT05329883 is sponsored by University Hospital, Ghent. The trial plans to enroll 1,000 participants.