Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double-J stent removal.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections, Stent Related Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Procedure Double-J stent removal
Outpatient ureteral stent removal without antibiotic prophylaxis
Primary outcome measures
- number of participants demonstrating a post-stent removal urinary tract infection [Time frame: 30 days after removal]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- University Hospital Ghent — Ghent
Identifiers
NCT: NCT05329883 · BC-10846