Continence Care Registry

Study Overview
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Brief Summary
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This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and other various aspects of using an intermittent catheter.

Detailed Description
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This observational research study aims to build a multinational ePRO registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research resulting from data generated from an ePRO registry will factor in end user perspectives on intermittent catheterization habits and behaviors and intermittent catheter performance to inform and guide healthcare providers, end users, and caregivers in making the most informed healthcare decisions regarding intermittent catheterization. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and various aspects of habits and behaviors, including health-related quality of life, of using an intermittent catheter.

Official Title
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Continence Care Registry (ConCaRe™)

Conditions
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Neurogenic Bladder, Non-Neurogenic Bladder

Intervention / Treatment
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* Device: Intermittent Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age; male or female. Is performing transurethral intermittent catheterization. Uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying. Must be able to provide informed consent and have no cognitive impairment that would hinder the ability to provide informed consent or self-reported data. Lives and has permanent residence in one of the countries that the study is being conducted at time of enrollment (USA, Canada, UK, Germany, France, The Netherlands, or Italy) Is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy. Is able to read and respond to the questionnaires in the language options provided for a given country (e.g. French Canadian or English for Canada) Exclusion Criteria: Performs non transurethral catheterization, e.g., stoma. Participating in a clinical study involving transurethral intermittent self-catheterization at the time of enrollment. Employee of Sponsor at the time of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>Individuals using an intermittent catheter to void urine through the urethra. Participants use their currently prescribed intermittent catheter per their clinician's standard of care. | Device: Intermittent Catheter<br>* Flexible tubular device used to drain urine from the bladder via the urethra by male, female, and pediatrics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of longitudinal continence care ePRO-based, direct-to-consumer registry | To build a longitudinal continence care ePRO-based, direct-to-consumer registry addressing overall intermittent self-catheterization product satisfaction, QoL, healthcare resource utilization associated with urinary symptoms, urinary tract infections and other complications including burden of ISC over time, and end-user product preference factors. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of intermittent self-catheterization habits and behaviors | To identify intermittent self-catheterization habits and behaviors, and enable meaningful intermittent catheter comparisons, including but not limited to product-specific outcomes related to urinary symptoms associated with ISC, frequency of UTI and other complications over time, and product satisfaction over time. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent Self Catheterization, Intermittent catheter, Urinary retention, Urinary incontinence, Urinary symptoms, Urinary tract infection (UTI)