Active — Not RecruitingNot Applicable

Continence Care Registry

United States600 participantsStarted 2021-05-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Creation of longitudinal continence care ePRO-based, direct-to-consumer registry

Timeframe: 5 years

Trial details

NCT IDNCT04924569

SponsorHollister Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-05

View on ClinicalTrials.gov More Neurogenic Bladder trials