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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current users of Hollister standard with tip hydrophilic intermittent catheters | Other | Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. |
|
| New users of Hollister standard with tip hydrophilic intermittent catheters | Other | Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Currently marketed Hydrophillic Intermittent Catheter | Device | Currently marketed Hollister standard with tip hydrophilic intermittent catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Test Hydrophilic Intermittent Catheter | Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter. | 10 days |
| Preference of Test Hydrophilic Intermittent Catheter | Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter. | 10 days |
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A. Inclusion Criteria for Arm 1
Subject who:
B. Exclusion Criteria for Arm 1
Subject who:
C. Inclusion Criteria for Arm 2
Subject who:
D. Exclusion Criteria for Arm 2
Subject who:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollister Incorporated | Libertyville | Illinois | 60048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
| FG001 | New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of Test Hydrophilic Intermittent Catheter | Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter. | Posted | Count of Participants | Participants | 10 days |
|
Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters. Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Potential viral infection | Infections and infestations | Systematic Assessment | Probably not related to study product. Mild severity. Subject reported increased fatigue and muscular aches. Undiagnosed but most likely due to viral infection. No urinary tract infection present. Self-resolved after few days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Global Clinical Affairs | Hollister Incorporated | +1 224-206-2857 | sara.wegener@hollister.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2021 | Jul 27, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Test Hydrophilic Intermittent Catheter | Device | Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
|
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters |
Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Per protocol inclusion criteria, only males were eligible for participation. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements |
|
|
| Primary | Preference of Test Hydrophilic Intermittent Catheter | Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter. | Posted | Count of Participants | Participants | 10 days |
|
|
|
| 0 |
| 54 |
| 0 |
| 54 |
| 7 |
| 54 |
| EG001 | New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters. Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements | 0 | 7 | 0 | 7 | 1 | 7 |
|
| Ankle surgery | Surgical and medical procedures | Systematic Assessment | Unrelated to study product. Mild severity. Subject underwent ankle surgery. |
|
| Gastrointestinal discomfort | Gastrointestinal disorders | Systematic Assessment | Unrelated to study product. Mild severity. Subject reported loose stools. Self-resolved after few days. |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Probably not related to study product. Moderate severity. Subject undergoing bowel management program. History of urinary tract infections during bowel training. |
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| Urethral discomfort | Product Issues | Systematic Assessment | Possibly related to study product. Mild severity. Burning sensation while inserting urinary catheter for initial insertions. No other urinary or product complications present. |
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| Cloudy urine | Renal and urinary disorders | Systematic Assessment | Probably not related to study product. Mild in severity. Subject reports cloudy urine. Resolved after 48 hours. No other urinary complications present. |
|
| Reduced urine flow and hip spasticity | Renal and urinary disorders | Systematic Assessment | Possibly related to study product. Mild in severity. Subject reported sensation of incomplete bladder voiding and hip spasticity. Improper storage of study product led to potential kinking of catheter tube. Issue resolved after proper storage. |
|
| Potential urethral narrowing | Renal and urinary disorders | Systematic Assessment | Unrelated to study product. Moderate severity. Subject had difficulty inserting catheter due to potential urethral narrowing. This complication was present prior to use of study product and under the care of healthcare provider. |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 'Disagree' or 'Strongly disagree' |
|