Continence Care Registry (ConCaRe™)

Sponsor

Hollister Incorporated (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04924569

Collaborator

Parexel (Industry), Technomics Research (Industry)

600

Enrollment

Location

59.2

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Non-Neurogenic Neurogenic Bladder	Device: Intermittent Catheter

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Continence Care Registry (ConCaRe™)

Actual Study Start Date :

May 24, 2021

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Standard of Care 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 Flexible tubular device used to drain urine from the bladder via the urethra by male, female, and pediatrics.

Arm

Intervention/Treatment

Standard of Care

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

Flexible tubular device used to drain urine from the bladder via the urethra by male, female, and pediatrics.

Outcome Measures

Primary Outcome Measures

Creation of longitudinal continence care ePRO-based, direct-to-consumer registry [5 years]
To build a longitudinal continence care ePRO-based, direct-to-consumer registry addressing overall intermittent catheter product satisfaction, QoL, healthcare resource utilization associated with urinary symptoms, urinary tract infections and other complications, and associated factors to end-user product choice.

Secondary Outcome Measures

Identification of intermittent catheterization habits and behaviours [5 years]
To identify intermittent catheterization habits and behaviors, via the analysis of the continence care registry data, to enable meaningful product-related and burden of illness insights and comparisons. Habits and behaviors include frequency of self-intermittent catheterization, catheter choice and access, intermittent catheter related complications, and adherence to catheterization plan.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Is willing and able to complete electronic questionnaires in their preferred language (English, German, French, Italian, or Dutch) monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy.

Exclusion Criteria:

Performs non transurethral catheterization, e.g., stoma.
Participating in a clinical study involving transurethral intermittent catheterization at the time of enrollment.
Employee of Sponsor at the time of enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hollister Incorporated	Libertyville	Illinois	United States	60048

Sponsors and Collaborators

Hollister Incorporated
Parexel
Technomics Research

Investigators

Study Director: Norma Thorelli, MD, MBA, MPH, Hollister Incorporated
Principal Investigator: Barbara Kearns, RGN, BA, BSc, Hollister Incorporated
Principal Investigator: Jessica Simmons, DNP, APRN, FNP-C, CWON, DNC, Hollister Incorporated