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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376670 on ClinicalTrials.gov