Real-life Clinical Experience With a Minimally Invasive Syringe Adapter for Catheter Free Instillation of Intravesical Treatments
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Interstitial Cystitis, Chronic
- Sponsor
- Radboud University Medical Center
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Number of participants who reported success (in using syringe adapter) Yes/No
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Dick Janssen
MD PhD
Radboud University Medical Center
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.
Outcomes
Primary Outcomes
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
- Number of participants who use syringe adapter 3 years after initial assessment (yes/no)(1 yr)
- Total number of UTI's during syringe adapter use amongst all patients(6 months)
- PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)(6 months)
- PRO ; patient reported reasons to continue syringe adapter (5 options)(6 months)