Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.
The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.
The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).
The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device - intermittent catheter with a micro-hole zone | Experimental | A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse. |
|
| Comparator device - VaPro intermittent catheter | Active Comparator | Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational device - intermittent catheter with a micro-hole zone | Device | The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Flow-stop Episodes | Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying. From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec). Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves. | Immediately after the procedure/catheterization |
| Residual Urine at 1st Flow-stop | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying. Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g]. | When the first flow-stop appeared, the amount of voided urine was measured. |
| Number of Flow-stop Episodes | Flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop. | Immediately after catheterisation |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile. | The intra-catheter pressure at the drainage holes, measured at 1st flow stop, was identified from a sensor curve. | When the first flow-stop appeared, the pressure at the drainage holes was measured |
| Post-catheterisation Volume |
Inclusion Criteria:
Exclusion Criteria:
5. Has any known allergies towards ingredients in the investigational device
The device is a male catheter
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cecilie Rovsing, MD | Sanos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanos Clinic | Gandrup | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
The 42 recruited participants were randomized into the two intervention arms (the Intention to Treat, ITT), using a randomization sequence of 8. No participants were excluded or discontinued.
All but one subject completed all visits due to data missing for one subject at visit 2. Accordingly, 41 catheterisation profiles were recorded for the investigational device and 42 for the comparator. No adverse events were reported.
Between August 2022 and November 2022, 42 users were recruited for the study from one site (Denmark) and encompassed the safety population.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Then Comparator | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 8. At the first intervention, one catheterization was performed with the investigational device, followed by a washout period of 4-14 days. At the second intervention, one catheterization was performed with the comparator device. |
| FG001 | Comparator Then Investigational | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 8. At the first intervention, one catheterization was performed with the comparator device, followed by a washout period of 4-14 days. At the second intervention, one catheterization was performed with the investigational device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
| |||||||||||||
| Visit 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total ITT Population Baseline Measures | Each investigation arm consisted of two test visits with 4-14 days of washout between each cross-over. On each visit, the participants underwent one intermittent catheterization performed by a trained nurse, through the urethra, draining the bladder, and testing a different intermittent catheter at each visit according to the randomization scheme. One catheterization with the investigational device which was a ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. And one catheterization was with the comparator device which was a ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a Hollister VaPro, in the sizes CH12 or CH14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Number of Flow-stop Episodes | Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying. From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec). Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves. | The full analysis set | Posted | Mean | 95% Confidence Interval | Flow stop episodes | Immediately after the procedure/catheterization |
|
Each participant was enrolled for 2x 1-14 days, thus a maximum of 28 days
The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 42 participants.
An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator or to the investigational device.
Not provided
| 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 | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 8. At the first intervention, one catheterization was performed with the investigational device, followed by a washout period of 4-14 days. At the second intervention, one catheterization was performed with the comparator device. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Writer | Coloplast, Clinical strategies | +4549112057 | dkmhla@coloplast.com |
Not provided
| 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 | Aug 2, 2022 | Feb 27, 2025 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator device -VaPro intermittent catheter | Device | The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. |
|
Post-catheterisation volume measured with a bladder Scanner assessed by the average of 3 consecutive measurements [mL] |
| Immediately after catheterisation |
| COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | 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 |
|
| Number of participants with neurogenic bladder dysfunction | Count of Participants | Participants |
|
| Number of participants with non-neurogenic bladder dysfunction | Count of Participants | Participants |
|
| OG001 | Comparator Device - VaPro Intermittent Catheter | Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14 (which correspond to the external diameter measured in millimeters (Charrière scale: Ch, CH)). The catheterization was performed by a trained nurse. Comparator device -VaPro intermittent catheter: The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use. |
|
|
|
| Primary | Residual Urine at 1st Flow-stop | The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying. Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g]. | The intention to treat population (full analysis set) constituted all randomized subjects with valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | 95% Confidence Interval | mL | When the first flow-stop appeared, the amount of voided urine was measured. |
|
|
|
|
| Primary | Number of Flow-stop Episodes | Flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Number | 95% Confidence Interval | Flow stop episodes | Immediately after catheterisation |
|
|
|
|
| Other Pre-specified | Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile. | The intra-catheter pressure at the drainage holes, measured at 1st flow stop, was identified from a sensor curve. | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | 95% Confidence Interval | mbar | When the first flow-stop appeared, the pressure at the drainage holes was measured |
|
|
|
|
| Other Pre-specified | Post-catheterisation Volume | Post-catheterisation volume measured with a bladder Scanner assessed by the average of 3 consecutive measurements [mL] | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Mean | 95% Confidence Interval | mL | Immediately after catheterisation |
|
|
|
|
| Post-Hoc | Probability of a Positive Test for Hematuria | Haematuria measured with a dipstick in the catheterised urine | The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints. | Posted | Number | 95% Confidence Interval | probability of positive test | Immediately after catheterisation |
|
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Comparator Device | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 8. At the first intervention, one catheterization was performed with the comparator device, followed by a washout period of 4-14 days. At the second intervention, one catheterization was performed with the investigational device. | 0 | 42 | 0 | 42 | 0 | 42 |
Not provided
| 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 |