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OpenTrials
Active, Not Recruiting

NCT Number: NCT04924569

Continence Care Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 5 years

    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.

Secondary outcomes

  1. Identification of intermittent self-catheterization habits and behaviors

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Collaborators

  • Parexel

Registry information

Official study title

Continence Care Registry (ConCaRe™)

Acronym: ConCaRe™

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jun 14, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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