Neurogenic BladderConCaRe™NCT04924569

Continence Care Registry

An observational study of Neurogenic Bladder and Non-Neurogenic Bladder, run by Hollister Incorporated at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neurogenic Bladder, Non-Neurogenic Bladder
How many people: 600 participants
Where: 1 siteUnited States
Study dates: 24 May 2021to May 2030
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Sponsor-curated customer databases and printed EC/IRB approved advertisements targeted to intermittent catheter consumers from the USA, Canada, UK, Italy, France, Germany, and The Netherlands that may be distributed by clinicians, mail, website, conferences and other consumer contacts.

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hollister Incorporated
Libertyville, Illinois, 60048

Other trials in United States

About this study

Official title: Continence Care Registry (ConCaRe™)

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.

Read the 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.

Conditions: Neurogenic Bladder, Non-Neurogenic Bladder
Keywords: Intermittent Self Catheterization, Intermittent catheter, Urinary retention, Urinary incontinence, Urinary symptoms, Urinary tract infection (UTI)
Medical subject headings: Urinary Bladder, Neurogenic, Urinary Retention, Urinary Incontinence, Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04924569
Study group	Role	What they receive
Standard of Care		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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Creation of longitudinal continence care ePRO-based, direct-to-consumer registry
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.
Measured: 5 years

Secondary outcomes (1)

Identification of intermittent self-catheterization habits and behaviors
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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 2021May 2030

First posted14 Jun 2021
Study start24 May 2021
Primary completionMay 2030 (estimated)
Study completionMay 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Neurogenic BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 600 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT04924569
Sponsor's protocol ID: 6016-CONT
Acronym: ConCaRe™
Status last verified: May 2026
First submitted: 31 May 2021
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

New PW. The evidence supporting single-use intermittent catheters in people with spinal cord injury. Spinal Cord Ser Cases. 2020 Sep 30;6(1):89. doi: 10.1038/s41394-020-00339-5.
PubMed 32999268
Romo PGB, Smith CP, Cox A, Averbeck MA, Dowling C, Beckford C, Manohar P, Duran S, Cameron AP. Non-surgical urologic management of neurogenic bladder after spinal cord injury. World J Urol. 2018 Oct;36(10):1555-1568. doi: 10.1007/s00345-018-2419-z. Epub 2018 Jul 26.
PubMed 30051263
Letica-Kriegel AS, Salmasian H, Vawdrey DK, Youngerman BE, Green RA, Furuya EY, Calfee DP, Perotte R. Identifying the risk factors for catheter-associated urinary tract infections: a large cross-sectional study of six hospitals. BMJ Open. 2019 Feb 21;9(2):e022137. doi: 10.1136/bmjopen-2018-022137.
PubMed 30796114
Kinnear N, Barnett D, O'Callaghan M, Horsell K, Gani J, Hennessey D. The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Neurourol Urodyn. 2020 Feb;39(2):854-862. doi: 10.1002/nau.24253. Epub 2019 Dec 17.
PubMed 31845396
Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.
PubMed 32172456
Rognoni C, Tarricone R. Intermittent catheterisation with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses. BMC Urol. 2017 Jan 10;17(1):4. doi: 10.1186/s12894-016-0191-1.
PubMed 28073354
Logan, K. Intermittent self-catheterisation in men. Trends Urology & Men Health, 2018;9: 11-14.
International Organization for Standardization. Clinical investigation of medical devices for human subjects-Good clinical practice 2011;ISO 14155.
ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.
PubMed 17868186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neurogenic Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Continence Care Registry (ConCaRe™)
ClinicalTrials.gov ID: NCT04924569
Acronym / sponsor ID: ConCaRe™ / 6016-CONT
Conditions: Neurogenic Bladder, Non-Neurogenic Bladder
Keywords: Intermittent Self Catheterization, Intermittent catheter, Urinary retention, Urinary incontinence, Urinary symptoms, Urinary tract infection (UTI)
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Hollister IncorporatedIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 24 May 2021 (actual)
Primary completion: May 2030 (estimated)
Study completion: May 2030 (estimated)
First posted: 14 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 1

Arm	Type	Receives
Standard of Care	–	–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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Sponsor-curated customer databases and printed EC/IRB approved advertisements targeted to intermittent catheter consumers from the USA, Canada, UK, Italy, France, Germany, and The Netherlands that may be distributed by clinicians, mail, website, conferences and other consumer contacts.

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

1 secondary outcome

Identification of intermittent self-catheterization habits and behaviors
Time frame: 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Background: PubMed 32999268New PW. The evidence supporting single-use intermittent catheters in people with spinal cord injury. Spinal Cord Ser Cases. 2020 Sep 30;6(1):89. doi: 10.1038/s41394-020-00339-5.
Background: PubMed 30051263Romo PGB, Smith CP, Cox A, Averbeck MA, Dowling C, Beckford C, Manohar P, Duran S, Cameron AP. Non-surgical urologic management of neurogenic bladder after spinal cord injury. World J Urol. 2018 Oct;36(10):1555-1568. doi: 10.1007/s00345-018-2419-z. Epub 2018 Jul 26.
Background: PubMed 30796114Letica-Kriegel AS, Salmasian H, Vawdrey DK, Youngerman BE, Green RA, Furuya EY, Calfee DP, Perotte R. Identifying the risk factors for catheter-associated urinary tract infections: a large cross-sectional study of six hospitals. BMJ Open. 2019 Feb 21;9(2):e022137. doi: 10.1136/bmjopen-2018-022137.
Background: PubMed 31845396Kinnear N, Barnett D, O'Callaghan M, Horsell K, Gani J, Hennessey D. The impact of catheter-based bladder drainage method on urinary tract infection risk in spinal cord injury and neurogenic bladder: A systematic review. Neurourol Urodyn. 2020 Feb;39(2):854-862. doi: 10.1002/nau.24253. Epub 2019 Dec 17.
Background: PubMed 32172456Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.
Background: PubMed 28073354Rognoni C, Tarricone R. Intermittent catheterisation with hydrophilic and non-hydrophilic urinary catheters: systematic literature review and meta-analyses. BMC Urol. 2017 Jan 10;17(1):4. doi: 10.1186/s12894-016-0191-1.
BackgroundLogan, K. Intermittent self-catheterisation in men. Trends Urology & Men Health, 2018;9: 11-14.
BackgroundInternational Organization for Standardization. Clinical investigation of medical devices for human subjects-Good clinical practice 2011;ISO 14155.
Background: PubMed 17868186ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.
Individual participant dataSharing planned: No

Related trials for Neurogenic Bladder

Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
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RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neurogenic Bladder and Non-Neurogenic Bladder, run by Hollister Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Creation of longitudinal continence care ePRO-based, direct-to-consumer registry (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924569, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.