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

May 13, 2022 updated by: Manu Bilsen, MD, Leiden University Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first UTI recurrence after initiation of IAI
Time Frame: First 6 months of IAI
First 6 months of IAI
Number of UTI recurrences
Time Frame: First 6 months of IAI
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
First 6 months of IAI
Number of patients that wish to (dis)continue IAI
Time Frame: 6 months after initiation of 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
Time Frame: 6 months after initiation of IAI
6 months after initiation of IAI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2022

Primary Completion (ANTICIPATED)

September 20, 2022

Study Completion (ANTICIPATED)

September 20, 2022

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (ACTUAL)

May 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMODIV2_2022013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on Intravesical aminoglycoside instillations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe