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

NCT05376670 | Completed FDA Drug

• 1 other identifier: nWMODIV2_2022013
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections; Recurrent Urinary Tract Infection

Keywords

Intravesical treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

Intravesical aminoglycoside instillations DRUG

Overnight instillation of an aminoglycoside (CIC), varying treatment regimens

Also known as: Intravesical gentamicin, tobramycin or amikacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Tobramycin; Amikacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Manu Bilsen, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, Department of Infectious Diseases, Principle Investigator

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 17, 2022
• Study Start: April 20, 2022
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

NL (1)