An observational study in Urinary Tract Infections and Recurrent Urinary Tract Infection, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Leiden University Medical Center · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 44 is below the median of 240 across 2,136 observational studies indexed under Infections.
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The study population will include adult male and female patients receiving IAI for recurrent UTI at the infectious diseases outpatient clinic of the Leiden University Medical Centre. A proportion of study participants will have urological and/or neurological comorbidities and a history of other prophylactic treatments for recurrent UTI.
Exclusion Criteria:
Overnight instillation of an aminoglycoside (CIC), varying treatment regimens
Also known as: Intravesical gentamicin, tobramycin or amikacin
Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)
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)
Time frame: 1 year
Time to first UTI recurrence after initiation of IAI
Time frame: First 6 months of IAI
Number of UTI recurrences
Time frame: First 6 months of IAI
Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)
Time frame: First 6 months of IAI
Number of patients that wish to (dis)continue IAI
Time frame: 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
Time frame: 6 months after initiation of IAI
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center