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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravesical aminoglycoside instillations | Drug | Overnight instillation of an aminoglycoside (CIC), varying treatment regimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Manu Bilsen, MD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333 ZA | Netherlands |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Carbohydrates |