Real-life Clinical Experience With Ialuadapter Study (Ialuadapter)

August 1, 2024 updated by: Dick Janssen, Radboud University Medical Center

Real-life Clinical Experience With a Minimally Invasive Syringe Adapter for Catheter Free Instillation of Intravesical Treatments

A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Intravesical treatment is currently dependent on catheterization which can cause urethral discomfort and risk of urinary tract infections in selected patient groups such as interstitial cystitis / bladder pain syndrome (IC/BPS), overactive bladder syndrome (OAB) and recurrent urinary tract infections (rUTI). This study describes real-life clinical experience of a minimally invasive syringe adapter (Ialudapter®) for catheter-free instillation of intravesical treatment.

Methods A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

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

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 HB
        • Radboudumc

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

  • Patients with IC/BPS, recurrent UTIs and/or OAB
  • Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).

Description

Inclusion Criteria:

  • Patients with IC/BPS, recurrent UTIs and/or OAB
  • Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).

Exclusion Criteria:

  • Patients with a high post-void residue of >100ml or with an indwelling catheter were excluded from the analyses.
  • Patients who cannot sign 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
61 patients evaluated
with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7)
Device: Ialuadapter
minimally invasive syringe device for bladder catherization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who reported success (in using syringe adapter) Yes/No
Time Frame: 6 months
pt self reported general assessment of successful instillation using the syringe adapter
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)
Time Frame: 6 months
patient reported subjective reasons for trying the syringe adapter: options: urethral pain, convenience, fear of catheter, urine tract infections or other
6 months
Total number of UTI's during syringe adapter use amongst all patients
Time Frame: 6 months
Recorded UTI's reported in electronic patient database during the time they used syringe adapter
6 months
Number of participants who use syringe adapter 3 years after initial assessment (yes/no)
Time Frame: 1 yr
long term adherence to syringe adapter (still using in in clinical practice)
1 yr
PRO ; patient reported reasons to continue syringe adapter (5 options)
Time Frame: 6 months
Subjective reasons given by patients for continuing with syringe adapter compared to regular catheter. Option were : hope for fewer urine tract infections, less pain, easier to use, self -sustainability, other)
6 months

Collaborators and Investigators

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

Sponsor

Radboud 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)

November 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ialudapter Study

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

No

Studies a U.S. FDA-regulated device product

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.

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