Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
NCT05376670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44
Last updated 2023-03-08
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, e.g. regarding the development of (pre)malignant bladder lesions.
Conditions
- Urinary Tract Infections
- Recurrent Urinary Tract Infection
Interventions
- DRUG
-
Intravesical aminoglycoside instillations
Overnight instillation of an aminoglycoside (CIC), varying treatment regimens
Sponsors & Collaborators
-
Leiden University Medical Center
lead OTHER
Principal Investigators
-
Manu Bilsen, MD · Leiden University Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-20
- Primary Completion
- 2023-03-07
- Completion
- 2023-03-07
- FDA Drug
- Yes
Countries
- Netherlands
Study Locations
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