Continence Care Registry

Neurogenic Bladder Clinical Trial

— ConCaRe™  

Official title:

Continence Care Registry (ConCaRe™)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924569
• Other study ID #: 6016-CONT
• Status: Recruiting
• Start date: May 24, 2021
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Hollister Incorporated
• Contact: Mackenzie Juckett
• Phone: +18479321845
• Email: mackenzie.juckett[@]hollister.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Device:
• Intermittent Catheter
Flexible tubular device used to drain urine from the bladder via the urethra by male, female, and pediatrics.

Locations

Country	Name	City	State
United States	Hollister Incorporated	Libertyville	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Hollister Incorporated	Parexel, Technomics Research

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

Logan, K. Intermittent self-catheterisation in men. Trends Urology & Men Health, 2018;9: 11-14.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years
Secondary	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.	5 years