Continence Care Registry (ConCaRe™)

  • STATUS
    Recruiting
  • End date
    May 14, 2026
  • participants needed
    600
  • sponsor
    Hollister Incorporated
Updated on 14 June 2022

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.

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.

Details
Condition Neurogenic Bladder, Non-Neurogenic Neurogenic Bladder
Treatment Intermittent Catheter
Clinical Study IdentifierNCT04924569
SponsorHollister Incorporated
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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