Clinical trial NCT06540248: Real-life Clinical Experience With Ialuadapter Study
Official title: Real-life Clinical Experience With a Minimally Invasive Syringe Adapter for Catheter Free Instillation of Intravesical Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis, Chronic
Overactive Bladder Syndrome
Recurrent Urinary Tract Infection
Keywords: IALUDAPTER
intravesical therapy
GAG therapy
Intravesical treatment
IC/BPS
recurrent urine tract infection
catheterization
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who reported success (in using syringe adapter) Yes/No
timeFrame: 6 months
Secondary outcomes:
measure: PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)
timeFrame: 6 months
measure: Total number of UTI's during syringe adapter use amongst all patients
timeFrame: 6 months
measure: Number of participants who use syringe adapter 3 years after initial assessment (yes/no)
timeFrame: 1 yr
measure: PRO ; patient reported reasons to continue syringe adapter (5 options)
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: