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

Completed

• Conditions: Urinary Tract Infections; Recurrent Urinary Tract Infection

• Registration Number: NCT05376670
• Lead Sponsor: Leiden University Medical Center

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, e.g. regarding the development of (pre)malignant bladder lesions.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-17
• Status Verified: 2023-03
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)	1 year	Measured with Treatment Satisfaction Questionnaire for Medication version II (TSQM-II), value ranging from 0 to 100 (with a score of 100 indicating the highest treatment satisfaction)

Secondary Outcome Measures

Name	Time	Method
Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)	First 6 months of IAI
Number of patients that wish to (dis)continue IAI	6 months after initiation of IAI
Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI	6 months after initiation of IAI
Number of UTI recurrences	First 6 months of IAI
Time to first UTI recurrence after initiation of IAI	First 6 months of IAI

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, South Holland, Netherlands