Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540248
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Real-life Clinical Experience With Ialuadapter Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-life Clinical Experience With a Minimally Invasive Syringe Adapter for Catheter Free Instillation of Intravesical Treatments
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ialuadapter
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 ICBPS n48 rUTI n6 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 ICBPS 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 ICBPS n48 rUTI n6 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
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 ICBPS n48 rUTI n6 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None