Real-life Clinical Experience With Ialuadapter Study

Radboud University Medical Center

Status: Completed

Conditions: Recurrent Urinary Tract Infection; Interstitial Cystitis, Chronic; Overactive Bladder Syndrome

Treatments: Device: Ialuadapter

Study type: Observational

Funder types: Other

Identifiers

NCT06540248

Ialudapter Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

61 participants in 1 patient group

61 patients evaluated

Description:

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

Treatment:

Device: Ialuadapter