Interstitial Cystitis, Chronic, Overactive Bladder Syndrome, Recurrent Urinary Tract Infection
Conditions
Keywords
IALUDAPTER, intravesical therapy, GAG therapy, Intravesical treatment, IC/BPS, recurrent urine tract infection, catheterization
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.
Interventions
DEVICEIaluadapter
minimally invasive syringe device for bladder catherization
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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) |
Countries
Netherlands
Outcome results
None listed