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A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73)where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
This investigation was a multi-centre, randomized, controlled crossover study including 73 male clean intermittent catheterization (CIC) users.
The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if participants allowed. Visit 0 included the screening-, inclusion-, and randomization phase of participants and at visit 1, participants performed a self-catheterization with the device according to their respective randomization scheme. This was followed by a dipstick test for hematuria. This constituted the Full Analysis Set (FAS) 1, consisting of 73 participants.
In the two 4-week test periods (T1 and T2, respectively) the participants catheterized at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for hematuria was performed daily.
For Visit 2 and 3, a sub-group of participants was invited for a clinical test visit during which participants were catheterized with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterization was performed followed by a self-catheterization, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterization, any residual urine left in the bladder was measured with a bladder scanner and hematuria was assessed with a dip-stick test. After the self-catheterization process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort.This constituted the Full Analysis Set (FAS) 2, consisting of 49 participants.
All participants completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For participants not part of clinic visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all participants were introduced to the second device to be tested for the next home-test period.
After the second home-test period, the study was terminated with a test visit 3 (V3), either in the clinic (for the subset group, FAS2) or a home visit by the nurse (the FAS1 group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device - intermittent catheter with micro-hole zone | Experimental | Single-use, sterile, hydrophilic coated intermittent male catheter. The external diameter is measured in millimeters (Charrière scale: Ch, CH) and the sizes available were CH12 and CH14 with a flexible tip and a micro-hole zone for urinary drainage. |
|
| Comparator device - standard intermittent catheter | Active Comparator | Single-use, sterile, hydrophilic coated intermittent male catheters (sizes CH12 and CH14) with sleeves: SpeediCath Flex, VaPro, VaPro Pocket, VaPro Plus and VaPro Plus Pocket. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational device - intermittent catheter with micro-hole zone | Device | Intermittent male catheter with micro-hole zone for urinary drainage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile | The residual urine at 1st flow-stop during catheterization (performed by a HCP) 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]. | Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization |
| Number of Flow-stop Episodes (HCP-led Catheterization) | Number of 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, at second and third clinic visit following 4 weeks of home catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Flow-stop Episodes (Self-led Catheterization) | Number of 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. |
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Inclusion Criteria:
Exclusion Criteria
Male users of intermittent urinary catheterizations to empty their bladder.
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| Name | Affiliation | Role |
|---|---|---|
| Nikesh thiruchelvam, Dr | NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanos Clinic | Gandrup | North Denmark | 9362 | Denmark | ||
| Rigshospitalet |
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) Then Comparator | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 8. During the first period, participants were catheterized with the investigational device during a first clinic visit, followed by a 4 weeks period of home catheterization. A sub-population were invited for a second clinic visit (V2) and were catheterized with the investigational device by an HCP and a self-catheterization, respectively. At the second intervention period, participants catheterized with the comparator device during another 4 weeks at home. The same sub-population took part in a third and final clinic visit (V3) and were catheterized by a HCP- and a self-catheterization, respectively. |
| FG001 | Comparator Device (Standard Intermittent Catheter, CH12/14) Then Investigational Device | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 8. During the first period, participants were catheterized with the comparator device during a first clinic visit (V1), followed by a 4 weeks period of home catheterization. A sub-population were invited for a second clinic visit (V2) and were catheterized with the comparator device by an HCP and a self-catheterization, respectively. At the second intervention period, participants catheterized with the investigational device during another 4 weeks at home. The same sub-population took part in a third and final clinic visit (V3) and were catheterized by a HCP- and a self-catheterization, respectively. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (V0, V1, T1, and V2) |
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| Period 1 (V2 Subpopulation) |
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| Period 2 (T2 and V3) |
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| Period 2 (V3 Subpopulation) |
|
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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 four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 included subject screening, enrollment, and randomization. Randomization was done centralized, randomly assigning subjects to two intervention sequences in block-sizes of four. Hence, the first group was catheterized with the investigational device at visit 0 and 1, followed by a test period at home (T1) and a follow-up visit (V2). Subsequently, the comparator device was tested during the next test period at home (T2) followed by a visit 3 which also terminated the study. The second group tested the devices in reversed order. The total study duration was approximately nine 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 Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile | The residual urine at 1st flow-stop during catheterization (performed by a HCP) 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]. | This population constituted a subset (=Full Analysis Set 2(FAS2)) of the all randomized subjects (FAS1, N=73). This subset FAS2 included 49 participant, who took part in both test periods at home (T1 and T2) and in clinic visits (V2 and V3) to acquire data related to the catheterization process and which supported the primary endpoints residual urine at first flow-stop and number of flow-stop episodes. | Posted | Mean | 95% Confidence Interval | mL | Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization |
The study consisted of four study visits in a clinic (V0-V3) and two 4-week test periods at home. Hence, the total study duration for the individual subject lasted approximately nine weeks.
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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 | As this study was a crossover study, each participant underwent catheterizations with both the investigational device and the comparator device. Safety population constitutes the full analysis set. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Malene Hornbak Landauro, Medical writer of Clinical strategies | Coloplast A/S | +4549112057 | dkmhla@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 | Nov 21, 2022 | Feb 27, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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This was a multi-centre, randomized, controlled crossover design. The total study duration for the individual participant was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73) where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
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| Comparator - standard intermittent catheter | Device | SpeediCath Flex, VaPro Pocket, VaPro Plus and VaPro Plus Pocket. |
|
| Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization |
| Residual Urine at 1st Flow Stop (Self-led Catheterization) | The residual urine at 1st flow-stop during catheterization (performed by the participant self) 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]. | Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization |
| Mean Red Blood Cell Concentration | The average (mean) Red blood cell concentration based on a dipstick test, collected daily during the two weeks of the home test period T1 and T2 [Erythrocytes/µL]. | Dipstick test for haematuria was performed daily were performed in week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period). |
| Positive Hematuria Event Post-catheterisation | Number of positive hematuria events (i.e., blood in urine) based on a dipstick test, collected daily during the final two weeks of the home test period T1 and T2 [positive/negative scale]. Positive value = blood in the urine. Negative value = no blood in the urine. | week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period). |
| Copenhagen |
| Denmark |
| Hopital Claude Huriez | Lille | 59037 | France |
| Hôpital Tenon | Paris | 75020 | France |
| Artimed | Kassel | Germany |
| Illingworth Research Group | Macclesfield | Cheshire | SK10 2XR | United Kingdom |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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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 |
|
| Number of participants with neurogenic bladder dysfunction | Count of Participants | Participants |
|
| Number of participants with non-neurogenic bladder dysfunction | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) | 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 during a first clinic visit, followed by a 4 weeks period of home catheterization, followed by a second clinic visit with a HCP- and a self-catheterization, respectively. At the second intervention, catheterizations with the comparator device were performed during a second 4 weeks period at home, followed by a third and final clinic visit with a HCP- and a self-catheterization, respectively. |
| OG001 | Comparator Device (Standard Intermittent Catheter, CH12/14) | 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 during a first clinic visit, followed by a 4 weeks period of home catheterization, followed by a second clinic visit with a HCP- and a self-catheterization, respectively. At the second intervention, catheterizations with the investigational device were performed during a second 4 weeks period at home, followed by a third and final clinic visit with a HCP- and a self-catheterization, respectively. |
|
|
|
| Primary | Number of Flow-stop Episodes (HCP-led Catheterization) | Number of 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. | This population constituted a subset (= Full analysis set (FAS)2) of the all randomized subjects (FAS1, N=73). This subset FAS2 included 49 participant, who took part in both test periods at home (T1 and T2) and in clinic visits (V2 and V3) to acquire data related to the catheterization process and which supported the primary endpoints residual urine at first flow-stop and number of flow-stop episodes. | Posted | Mean | 95% Confidence Interval | Flow stop episodes | Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization |
|
|
|
|
| Secondary | Number of Flow-stop Episodes (Self-led Catheterization) | Number of 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. | This population constituted a subset (FAS2) of the all randomized subjects (FAS1, N=73). This subset FAS2 included 49 participant, who took part in both test periods at home (T1 and T2) and in clinic visits (V2 and V3) to acquire data related to the catheterization process and which supported the primary endpoints residual urine at first flow-stop and number of flow-stop episodes. | Posted | Mean | 95% Confidence Interval | Flow stop episodes | Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization |
|
|
|
|
| Secondary | Residual Urine at 1st Flow Stop (Self-led Catheterization) | The residual urine at 1st flow-stop during catheterization (performed by the participant self) 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]. | This population constituted a subset (FAS2) of the all randomized subjects (FAS1, N=73). This subset FAS2 included 49 participant, who took part in both test periods at home (T1 and T2) and in clinic visits (V2 and V3) to acquire data related to the catheterization process and which supported the primary endpoints residual urine at first flow-stop and number of flow-stop episodes. | Posted | Mean | 95% Confidence Interval | mL | Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization |
|
|
|
|
| Secondary | Mean Red Blood Cell Concentration | The average (mean) Red blood cell concentration based on a dipstick test, collected daily during the two weeks of the home test period T1 and T2 [Erythrocytes/µL]. | Participants from the full analysis set during the first and second home period (FAS1) | Posted | Least Squares Mean | 95% Confidence Interval | erythrocytes per microliter | Dipstick test for haematuria was performed daily were performed in week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period). |
|
|
|
| Secondary | Positive Hematuria Event Post-catheterisation | Number of positive hematuria events (i.e., blood in urine) based on a dipstick test, collected daily during the final two weeks of the home test period T1 and T2 [positive/negative scale]. Positive value = blood in the urine. Negative value = no blood in the urine. | Participants from the full analysis set during the first and second home period, (FAS1). | Posted | Mean | 95% Confidence Interval | positive hematuria events | week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period). |
|
|
|
| 0 |
| 73 |
| 3 |
| 73 |
| 8 |
| 73 |
| EG001 | Comparator Device | As this study was a crossover study, each participant underwent catheterizations with both the investigational device and the comparator device. Safety population constitutes the full analysis set. | 1 | 73 | 0 | 73 | 8 | 73 |
| Urosepsis | Renal and urinary disorders | Non-systematic Assessment |
|
| unbalanced type 2 diabetes | Endocrine disorders | Non-systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Epididymit | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blood in urine | Renal and urinary disorders | Systematic Assessment |
|
| Gout | Infections and infestations | Systematic Assessment |
|
| Swollen foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stinging in urethra | Renal and urinary disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Micturition | Renal and urinary disorders | Systematic Assessment |
|
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |