Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention

NCT ID: NCT05376670

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2023-03-07

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections Recurrent Urinary Tract Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Intravesical aminoglycoside instillations

Overnight instillation of an aminoglycoside (CIC), varying treatment regimens

Intervention Type DRUG

Other Intervention Names

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Intravesical gentamicin, tobramycin or amikacin

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment

Exclusion Criteria

* Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes
* Receiving IAI as suppressive therapy for chronic prostatitis
* Presence of a chronic indwelling catheter
* Patient has objected to the use of his/her data
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Manu Bilsen, MD

MD, PhD student, Department of Infectious Diseases, Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manu Bilsen, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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nWMODIV2_2022013

Identifier Type: -

Identifier Source: org_study_id

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