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The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.
The total study duration for the individual subject will be up to 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device - newly developed intermittent compact catheter | Experimental | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. |
|
| Hollister Infyna Chic | Active Comparator | The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational device | Device | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL] | At Visit 1 and Visit 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Flowstops (Catheterisation Performed by a Healthcare Professional) | Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number]. | At Visit 1 and Visit 2 |
| Residual Volume Post Catheterisation |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort Measure by VAS (Only in DK) | Discomfort is measured by Visual Analogue Scale (VAS), which is measured on a 10 cm horizontal scale ranging from "no discomfort" at 0 cm to "worst possible discomfort" at 10 cm caused by the catheter, by drawing a vertical line indicating how the subject experienced the catheterization divided into the four following categories: Discomfort at insertion measured using the VAS (VAS) [cm] Discomfort at withdrawal measured using the VAS, [cm] Discomfort during emptying of bladder measured using the VAS, [cm] Discomfort at end of emptying the bladder measured using the VAS, [cm] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Andersen, MD | Odense Universitetshospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense Universitetshospital | Odense | 5000 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device First, Then Hollister Infyna Chic | Investigational device: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use. Comparator device: Hollister Infyna Chic, single-use compact catheter. |
| FG001 | Hollister Infyna Chic, Then Investigational Device | The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter. Comparator device: Hollister Infyna Chic, single-use compact catheter. Investigational device: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Visit 1) |
| |||||||||||||
| Second Intervention (Visit 2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total ITT Population Baseline Measures | As this study was a crossover study, each participant underwent catheterizations with both the investigational device and the comparator device. The study consisted of three study visits (V0-V2) . Visit 0 included subject enrollment, and randomization. Randomization was done centralized, randomly assigning subjects to two intervention sequences. Hence, the first group used the investigational device at the first follow-up visit (V1). Subsequently, the comparator device was used at the visit 2 which also terminated the study. The second group tested the devices in reversed order. The total study duration was up to two weeks for the individual subject |
| 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 | Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, [mL] | Posted | Least Squares Mean | 95% Confidence Interval | mL | At Visit 1 and Visit 2 |
|
Adverse events were registered from the individual's enrolment until termination in the study. The total study duration for the individual subject was between two days to two weeks, consisting of three site visits (V0-V2).
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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 | Investigational Device - Newly Developed Intermittent Compact Catheter | Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use. Investigational device: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use. Comparator device: Hollister Infyna Chic, single-use compact catheter. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstipation | Gastrointestinal disorders | Non-systematic Assessment |
The natural distribution of residual volume at 1st flow-stop values skews positively. This carries a high risk of influence by random occurrences of extreme values. These can occur without systematic relation to product or subject and can obscure interpretability of the analysis. To counter this effect, post hoc responder analyses were included, testing the benefit of treatment through the proportion of individuals who achieve the desired outcome, i.e., complete and effective bladder drainage.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian Riis Forman, Medical writer | Coloplast A/S | 49111756 | dkcrif@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 | Feb 27, 2023 | Sep 5, 2024 | 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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controlled crossover study
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| Comparator device | Device | Hollister Infyna Chic, single-use compact catheter. |
|
Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL], |
| At Visit 1 and Visit 2 |
| Number of Adverse Events | Count number of Adverse events, [number] | At Visit 1 and Visit 2 |
| At Visit 1 and Visit 2 |
| NOT COMPLETED |
|
| 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 |
|
| Hollister Infyna Chic |
The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter. Investigational device: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use. Comparator device: Hollister Infyna Chic, single-use compact catheter. |
|
|
| Secondary | Number of Flowstops (Catheterisation Performed by a Healthcare Professional) | Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), [number]. | Posted | Least Squares Mean | 95% Confidence Interval | Number of flow-stops | At Visit 1 and Visit 2 |
|
|
|
| Secondary | Residual Volume Post Catheterisation | Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), [mL], | Posted | Mean | Standard Deviation | mL | At Visit 1 and Visit 2 |
|
|
|
| Secondary | Number of Adverse Events | Count number of Adverse events, [number] | Posted | Number | Adverse events | At Visit 1 and Visit 2 |
|
|
|
| Other Pre-specified | Discomfort Measure by VAS (Only in DK) | Discomfort is measured by Visual Analogue Scale (VAS), which is measured on a 10 cm horizontal scale ranging from "no discomfort" at 0 cm to "worst possible discomfort" at 10 cm caused by the catheter, by drawing a vertical line indicating how the subject experienced the catheterization divided into the four following categories: Discomfort at insertion measured using the VAS (VAS) [cm] Discomfort at withdrawal measured using the VAS, [cm] Discomfort during emptying of bladder measured using the VAS, [cm] Discomfort at end of emptying the bladder measured using the VAS, [cm] | This analysis was only performed with the investigational device and only on the participants from sites in Denmark. | Posted | Mean | Standard Deviation | score on a scale | At Visit 1 and Visit 2 |
|
|
|
| Post-Hoc | Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter | Responder analysis involved testing the proportion of all catheterisations which achieved a residual volume of urine at first flow-stop of less than 10 milliliter. In this clinical investigation, responder analyses were introduced as an expansion of the data analyses due to the few extreme RV1 values, which presented a challenge to the predetermined statistical model. (see 'limitations and caveats' section for further details). Responder analyses evaluated the proportion of patients who achieved the positive treatment response threshold, highlighting individual patient responses rather than average effects across the entire population. Successful treatment responses were defined as individuals who achieved the desired outcome of catheterisation, i.e., complete and effective bladder emptying without repositioning, in terms flow-stops defined as zero flow-stops and in terms of complete emptying of the bladder was defined as an RV1<10 mL. | Posted | Mean | 95% Confidence Interval | percentage of catheterisations | At Visit 1 and Visit 2 |
|
|
|
| Post-Hoc | Response to Treatment, 0 Flow-stops | Responder analysis involved testing the proportion of all catheterisations which did not experience any flow-stops. In this clinical investigation, responder analyses were introduced as an expansion of the data analyses due to the few extreme RV1 values, which presented a challenge to the predetermined statistical model. (see 'limitations and caveats' section for further details). Responder analyses evaluated the proportion of patients who achieved the positive treatment response threshold, highlighting individual patient responses rather than average effects across the entire population. Successful treatment responses were defined as individuals who achieved the desired outcome of catheterisation, i.e., complete and effective bladder emptying without repositioning, in terms flow-stops defined as zero flow-stops and in terms of complete emptying of the bladder was defined as an RV1<10 mL. | Posted | Mean | 95% Confidence Interval | percentage of catheterisations | At Visit 1 and Visit 2 |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 1 |
| 73 |
| EG001 | Hollister Infyna Chic | The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter. Investigational device: Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (sizes CH12 and CH14) for urinary drainage. The investigational device is for single use. Comparator device: Hollister Infyna Chic, single-use compact catheter. | 0 | 72 | 0 | 72 | 1 | 72 |
| Pain when urinating | 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 |
| Title | Measurements |
|---|---|
|
| Discomfort when emptying |
|