Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05329883
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2022-03-25
Brief Title:
Multicentric Study on Infections of the Urinary Tract After Stent Removal MINUS-trial
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Multicentric Study on Infections of the Urinary Tract After Stent Removal MINUS-trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINUS
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
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 UTIs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None