Recurrent Urinary Tract Infection, Urinary Tract Infections
Conditions
Keywords
Intravesical treatment
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.
Interventions
DRUGIntravesical aminoglycoside instillations
Overnight instillation of an aminoglycoside (CIC), varying treatment regimens
Sponsors
Leiden University Medical Center
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to first UTI recurrence after initiation of IAI | First 6 months of IAI |
| Number of UTI recurrences | First 6 months of IAI |
| 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 |
Countries
Netherlands
Outcome results
None listed