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

NCT ID: NCT05329883

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Urinary Tract Infections; Stent Related Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Double-J stent removal

Outpatient ureteral stent removal without antibiotic prophylaxis

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Lucas Gent

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

General Hospital Groeninge

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ghent

Ghent, Eastern-Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

Thomas Tailly, MD

Role: primary

thomas.tailly@uzgent.be

+3293322276

Other Identifiers

BC-10846

Identifier Type: -

Identifier Source: org_study_id