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The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.
Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.
Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLINY reusable catheter 28 days | Experimental | The investigation is designed as an open-labelled, single-arm investigation, in which the reuse CLINY catheter will be compared to single use catheters at baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLINY catheter | Device | Subjects using a single use catheter for bladder management at inclusion. During the study period, subjects will use the reusable CLINY catheter for 28 test-days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. | The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score) | Baseline (day 0) and Termination (day 28). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Adverse Events during the study | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Andersen | Odense Universitetshospital | Principal Investigator |
| Nessn Azawi | Zealand University Hospital | Principal Investigator |
| Brian Kloster | Ålborg Universitetshospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense Universitetshospital | Odense | 5000 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | CLINY Reusable Catheter | Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CLINY Reusable Catheter | Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. | The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score) | The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (day 0) and Termination (day 28). |
|
28 days
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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 | CLINY Reusable Catheter | Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood in urine | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zenia Størling, Senior Director of Clinical Strategies | Coloplast | +4549111869 | dkzenst@coloplast.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 | Oct 24, 2022 | Oct 17, 2023 | Prot_SAP_000.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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The investigation is designed as an open-labelled, single-arm investigation including subjects currently using single use catheters.
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| years |
|
| Sex: Female, Male | 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 |
|
| Height, Continuous | Mean | Standard Deviation | Centimeters |
|
| Weight, Continuous | Mean | Standard Deviation | Kilograms |
|
| Reason for IC use, Categorical | Count of Participants | Participants |
|
| Right hand function, Categorical | Count of Participants | Participants |
|
| Left hand function, Categorical | Count of Participants | Participants |
|
| Urethral Sensitivity, Categorical | Count of Participants | Participants |
|
| Time since starting IC as bladder management method, Continuous (years) | Mean | Standard Deviation | years |
|
Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters. |
|
|
| Secondary | Adverse Events | Number of Adverse Events during the study | The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing). | Posted | Number | Adverse events | 28 days |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 8 |
| 39 |
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Tears in the urethra | Renal and urinary disorders | Non-systematic Assessment |
|
| Pain in urinary tract | Renal and urinary disorders | Non-systematic Assessment |
|
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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 |