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OpenTrials
Completed

NCT Number: NCT05376670

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

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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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Recurrent Urinary Tract Infection Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravesical aminoglycoside instillations

Drug

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

Other names: Intravesical gentamicin, tobramycin or amikacin

Primary outcomes

  1. Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)

    Time frame: 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 outcomes

  1. Time to first UTI recurrence after initiation of IAI

    Time frame: First 6 months of IAI

  2. Number of UTI recurrences

    Time frame: First 6 months of IAI

  3. Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)

    Time frame: First 6 months of IAI

  4. Number of patients that wish to (dis)continue IAI

    Time frame: 6 months after initiation of IAI

  5. 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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: INSTILMENT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 17, 2022
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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