Real-life Clinical Experience With Ialuadapter Study
- Conditions
- Recurrent Urinary Tract InfectionInterstitial Cystitis, ChronicOveractive Bladder Syndrome
- Interventions
- Device: Ialuadapter
- Registration Number
- NCT06540248
- Lead Sponsor
- Radboud University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 61 patients evaluated Ialuadapter with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7)
- Primary Outcome Measures
Name Time Method Number of participants who reported success (in using syringe adapter) Yes/No 6 months pt self reported general assessment of successful instillation using the syringe adapter
- Secondary Outcome Measures
Name Time Method Number of participants who use syringe adapter 3 years after initial assessment (yes/no) 1 yr long term adherence to syringe adapter (still using in in clinical practice)
Total number of UTI's during syringe adapter use amongst all patients 6 months Recorded UTI's reported in electronic patient database during the time they used syringe adapter
PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options) 6 months patient reported subjective reasons for trying the syringe adapter: options: urethral pain, convenience, fear of catheter, urine tract infections or other
PRO ; patient reported reasons to continue syringe adapter (5 options) 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)
Trial Locations
- Locations (1)
Radboudumc
🇳🇱Nijmegen, Gelderland, Netherlands