Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
- Conditions
- Urinary Tract InfectionsRecurrent 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
- 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
- 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