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Completed

NCT Number: NCT06540248

Real-life Clinical Experience With Ialuadapter Study

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.

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Key information

Conditions

Interstitial Cystitis, Chronic Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Overactive Bladder Syndrome Recurrent Urinary Tract Infection Urinary Bladder Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ialuadapter

Device

minimally invasive syringe device for bladder catherization

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: Ialuadapter

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

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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