Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05376670
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2022-04-28
Brief Title:
Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
Status:
COMPLETED
Status Verified Date:
2023-03
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:
INSTILMENT
Brief Summary:
Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance antibiotic allergies and intolerances Intravesical aminoglycoside instillations IAI have been shown to reduce recurrence rate without a short-term decline in kidney function or hearing Thus far treatment satisfaction has not yet been assessed while this may play an important role in treatment adherence and persistence Moreover there is no data on the long-term safety of IAI eg regarding the development of premalignant bladder lesions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None