Real-life Clinical Experience With Ialuadapter Study | NCT06540248

Studies
Real-life Clinical Experience With Ialuadapter Study

NCT06540248

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Aug 6, 2024Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Interstitial Cystitis, Chronic
Overactive Bladder Syndrome
Recurrent Urinary Tract Infection

Interventions

Ialuadapter

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Nov 30, 2023Actual

Completion Date

Nov 30, 2023Actual

First Submitted Date

Jul 1, 2024

First Submission Date that Met QC Criteria

Aug 1, 2024

First Posted Date

Aug 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2024

Last Update Posted Date

Aug 6, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dick Janssen, MD PhD, Radboud University Medical CenterPrincipal Investigator

Lead Sponsor

Radboud University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
61 patients evaluated		with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7)	Device: Ialuadapter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ialuadapter	Device	minimally invasive syringe device for bladder catherization	61 patients evaluated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants who reported success (in using syringe adapter) Yes/No	pt self reported general assessment of successful instillation using the syringe adapter	6 months

Secondary Outcomes

Measure	Description	Time Frame
PRO; patient reported reasons for trying syringe adapter in stead of regular catheter (5 options)	patient reported subjective reasons for trying the syringe adapter: options: urethral pain, convenience, fear of catheter, urine tract infections or other	6 months
Total number of UTI's during syringe adapter use amongst all patients

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboudumc		Nijmegen	Gelderland	6525 HB	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided