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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infections; Stent Related Infection
• Intervention / Treatment: Procedure: Double-J stent removal

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Belgium
  • Eastern-Flanders
    • Gent, Eastern-Flanders, Belgium, 9000
      • Recruiting
      • University Hospital Ghent
      • Contact: Thomas Tailly, MD; Phone Number: +3293322276; Email: thomas.tailly@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Urinary Tract Infection; Ureterorenoscopy; Percutaneous Nephrolithotomy; Ureteral stent removal; Double-J stent; Endourology
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: BC-10846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No