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

NCT05329883 | Recruiting DMC

• 1 other identifier: BC-10846
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections; Stent Related Infection

Keywords

Urinary Tract Infection; Ureteral stent removal; Double-J stent; Ureterorenoscopy; Percutaneous Nephrolithotomy; Endourology

Outcome Measures

Primary Outcomes (1)

• number of participants demonstrating a post-stent removal urinary tract infection

  For this outcome measure, a urinary tract infection is defined as a urine sample demonstrating an identified uropathogen with at least 10.000 colony forming units in a patient demonstrating symptoms of a urinary tract infection after removal of a ureteral stent. Asymptomatic bacteriuria will not be considered a positive outcome.

  30 days after removal

Interventions

Double-J stent removal PROCEDURE

Outpatient ureteral stent removal without antibiotic prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate in the study

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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• AZ Sint-Lucas Gent: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• General Hospital Groeninge: collaborator
• University of British Columbia: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

University Hospital Ghent

Ghent, Eastern-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 15, 2022
• Study Start: November 25, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)