Continence Care Registry

NCT04924569 | Active Not Recruiting

• 1 other identifier: 6016-CONT
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder; Non-Neurogenic Bladder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identification of intermittent self-catheterization habits and behaviors

  5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hollister Incorporated: lead
• Parexel: collaborator
• Technomics Research: collaborator

Study Sites (1)

Hollister Incorporated

Libertyville, Illinois, 60048, United States

Location

Related Publications (9)

• 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.

  PMID: 32999268 BACKGROUND

• 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.

  PMID: 30051263 BACKGROUND

• 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.

  PMID: 30796114 BACKGROUND

• 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.

  PMID: 31845396 BACKGROUND

• 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.

  PMID: 32172456 BACKGROUND

• 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.

  PMID: 28073354 BACKGROUND

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

  BACKGROUND

• International Organization for Standardization. Clinical investigation of medical devices for human subjects-Good clinical practice 2011;ISO 14155.

  BACKGROUND

• ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.

  PMID: 17868186 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Retention; Urinary Incontinence; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Infections

Study Officials

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

  Hollister Incorporated

  PRINCIPAL INVESTIGATOR

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

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 14, 2021
• Study Start: May 24, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)