Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention

Urinary Tract Infections Clinical Trial

— INSTILMENT  

Official title:

Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376670
• Other study ID #: nWMODIV2_2022013
• Status: Completed
• Start date: April 20, 2022
• Est. completion date: March 7, 2023

Study information

• Verified date: March 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Intravesical aminoglycoside instillations
Overnight instillation of an aminoglycoside (CIC), varying treatment regimens

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Time to first UTI recurrence after initiation of IAI		First 6 months of IAI
Secondary	Number of UTI recurrences		First 6 months of IAI
Secondary	Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)		First 6 months of IAI
Secondary	Number of patients that wish to (dis)continue IAI		6 months after initiation of IAI
Secondary	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