Continence Care Registry

Active, not recruiting

• Conditions: Neurogenic Bladder; Non-Neurogenic Bladder
• Interventions: Device: Intermittent Catheter

• Registration Number: NCT04924569
• Lead Sponsor: Hollister Incorporated

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.

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 Timeline

• Study Start: 2021-05-24
• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Is at least 18 years of age; male or female.
2. Is performing transurethral intermittent catheterization.
3. Uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying.
4. 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.
5. 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)
6. Is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy.
7. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of Care	Intermittent Catheter	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.

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
Identification of intermittent self-catheterization habits and behaviors	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.

Trial Locations

Locations (1)

Hollister Incorporated; 🇺🇸 Libertyville, Illinois, United States