N/A
N=62
Consumer Evaluation of Intermittent Catheter Product Modifications
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT04619992 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Acceptability of Test Hydrophilic Intermittent Catheter — 45; 4; 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Currently marketed Hydrophillic Intermittent Catheter (Device); Test Hydrophilic Intermittent Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Hollister Incorporated
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability of Test Hydrophilic Intermittent Catheter |
45; 4; 4; 2; 5; 1 | — |
| PRIMARY Preference of Test Hydrophilic Intermittent Catheter |
35; 4; 11; 2; 8; 1 | — |
Summary
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
Eligibility Criteria
A. Inclusion Criteria for Arm 1
Subject who:
- is male and at least 18 years of age
- has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
B. Exclusion Criteria for Arm 1
Subject who:
- is currently undergoing chemotherapy, radiation or steroid therapy
- has a symptomatic urinary tract infection (UTI)
- is currently using a coude intermittent catheter product to perform catheterization
- performs non-urethral catheterization
C. Inclusion Criteria for Arm 2
Subject who:
- is male and at least 18 years of age
- has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month
D. Exclusion Criteria for Arm 2
Subject who:
- is currently undergoing chemotherapy, radiation or steroid therapy
- has a symptomatic urinary tract infection (UTI)
- is currently using a coude intermittent catheter product to perform catheterization
- performs non-urethral catheterization
- is unable to use a Hollister standard with tip hydrophilic intermittent catheter
Data sourced from ClinicalTrials.gov (NCT04619992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.