Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
600 participants
OBSERVATIONAL
2021-05-24
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Technomics Research
INDUSTRY
Hollister Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jessica Simmons, DNP, APRN, FNP-C, CWON, DNC
Role: PRINCIPAL_INVESTIGATOR
Hollister Incorporated
Diane Newman, D.N.P. F.A.A.N. B.C.B.-P.M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Hollister Incorporated
Libertyville, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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6016-CONT
Identifier Type: -
Identifier Source: org_study_id
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