Real-life Clinical Experience With Ialuadapter Study

NCT ID: NCT06540248

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Interstitial Cystitis, Chronic Overactive Bladder Syndrome Recurrent Urinary Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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61 patients evaluated

with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7)

Ialuadapter

Intervention Type DEVICE

minimally invasive syringe device for bladder catherization

Interventions

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Ialuadapter

minimally invasive syringe device for bladder catherization

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dick Janssen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Ialudapter Study

Identifier Type: -

Identifier Source: org_study_id

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