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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

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
NameTimeMethod
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
NameTimeMethod
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 IAI6 months after initiation of IAI
Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI6 months after initiation of IAI
Number of UTI recurrencesFirst 6 months of IAI
Time to first UTI recurrence after initiation of IAIFirst 6 months of IAI

Trial Locations

Locations (1)

Leiden University Medical Center

🇳🇱

Leiden, South Holland, Netherlands

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