ACTIVE_NOT_RECRUITING

Continence Care Registry

Conditions

Neurogenic Bladder Non-Neurogenic Bladder Intermittent Self Catheterization Intermittent catheter Urinary retention Urinary incontinence Urinary symptoms Urinary tract infection (UTI)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Continence Care Registry (ConCaRe™)

Quick Facts

Study Start:2021-05-24

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04924569

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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.

Inclusion Criteria

Exclusion 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)

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.

Contacts and Locations

Principal Investigator

Jessica Simmons, DNP, APRN, FNP-C, CWON, DNC

PRINCIPAL_INVESTIGATOR

Hollister Incorporated

Diane Newman, D.N.P. F.A.A.N. B.C.B.-P.M.D.

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Hollister Incorporated

Libertyville, Illinois, 60048

United States

Collaborators and Investigators

Sponsor: Hollister Incorporated

Jessica Simmons, DNP, APRN, FNP-C, CWON, DNC, PRINCIPAL_INVESTIGATOR, Hollister Incorporated
Diane Newman, D.N.P. F.A.A.N. B.C.B.-P.M.D., PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-24

Study Completion Date2026-05

Study Record Updates

Study Start Date2021-05-24

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Intermittent Self Catheterization
Intermittent catheter
Urinary retention
Urinary incontinence
Urinary symptoms
Urinary tract infection (UTI)

Additional Relevant MeSH Terms

Neurogenic Bladder
Non-Neurogenic Bladder