Retention, Urinary, Urinary Incontinence
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInvestigational device - intermittent catheter with a micro-hole zone
The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
DEVICEComparator device -VaPro intermittent catheter
The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is Male 2. Is at least 18 years of age and has full legal capacity 3. Has given written informed consent 4. Has signed letter of authority (only DK) 5. Has used clean intermittent catheterisation CH12 or CH14 for at least one month 6. Use intermittent catheterisation as the primary bladder emptying method 7. Is able (assessed by investigator) and willing to follow study procedures
Exclusion criteria
1. Is participating in any other clinical study during this investigation 2. Has previous participated in this study 3. Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris 5\. Has any known allergies towards ingredients in the investigational device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Flow-stop Episodes | Immediately after the procedure/catheterization | 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. |
| Residual Urine at 1st Flow-stop | When the first flow-stop appeared, the amount of voided urine was measured. | 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 \[g\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile. | When the first flow-stop appeared, the pressure at the drainage holes was measured | The intra-catheter pressure at the drainage holes, measured at 1st flow stop, was identified from a sensor curve. |
| Post-catheterisation Volume | Immediately after catheterisation | Post-catheterisation volume measured with a bladder Scanner assessed by the average of 3 consecutive measurements \[mL\] |
Countries
Denmark
Participant flow
Recruitment details
Between August 2022 and November 2022, 42 users were recruited for the study from one site (Denmark) and encompassed the safety population.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Total ITT Population Baseline Measures | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 28 Participants | — |
| Age, Categorical Between 18 and 65 years | 14 Participants | — |
| Age, Continuous | 68 years | — |
| Number of participants with neurogenic bladder dysfunction | 13 Participants | — |
| Number of participants with non-neurogenic bladder dysfunction | 29 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 42 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 42 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
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.
Time frame: Immediately after the procedure/catheterization
Population: The full analysis set
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) | Number of Flow-stop Episodes | 0.17 Flow stop episodes |
| Comparator Device - VaPro Intermittent Catheter | Number of Flow-stop Episodes | 1.09 Flow stop episodes |
p-value: <0.0595% CI: [0.05, 0.44]Mixed Models Analysis
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.
Time frame: Immediately after catheterisation
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) | Number of Flow-stop Episodes | 0.17 Flow stop episodes |
| Comparator Device - VaPro Intermittent Catheter | Number of Flow-stop Episodes | 1.09 Flow stop episodes |
Comparison: This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.p-value: 0.0595% CI: [0.05, 0.44]Mixed Models Analysis
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 \[g\].
Time frame: When the first flow-stop appeared, the amount of voided urine was measured.
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) | Residual Urine at 1st Flow-stop | 5.10 mL |
| Comparator Device - VaPro Intermittent Catheter | Residual Urine at 1st Flow-stop | 39.40 mL |
Comparison: This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.p-value: 0.0595% CI: [14.69, 53.91]Mixed Models Analysis
Other Pre-specified
Post-catheterisation Volume
Post-catheterisation volume measured with a bladder Scanner assessed by the average of 3 consecutive measurements \[mL\]
Time frame: Immediately after catheterisation
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) | Post-catheterisation Volume | 5.92 mL |
| Comparator Device - VaPro Intermittent Catheter | Post-catheterisation Volume | 7.13 mL |
p-value: 0.0595% CI: [-11.1, 13.51]Mixed Models Analysis
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.
Time frame: When the first flow-stop appeared, the pressure at the drainage holes was measured
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) | Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile. | -16.14 mbar |
| Comparator Device - VaPro Intermittent Catheter | Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile. | -111.83 mbar |
Comparison: The intra-catheter pressure at flow stop was analysed in a general linear mixed model with subject included as a random component.p-value: 0.0595% CI: [-137.69, -53.7]Mixed Models Analysis
Post Hoc
Probability of a Positive Test for Hematuria
Haematuria measured with a dipstick in the catheterised urine
Time frame: Immediately after catheterisation
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) | Probability of a Positive Test for Hematuria | 0.10 probability of positive test |
| Comparator Device - VaPro Intermittent Catheter | Probability of a Positive Test for Hematuria | 0.29 probability of positive test |
Comparison: Analyzed using a generalized linear mixed model, modelling the probability of a positive outcome. Evidence of effect in favour of the MHZC was concluded if the upper 95% confidence limit (CL) of the odds ratio, O.R. was less than 1.p-value: 0.0595% CI: [0.07, 0.96]Mixed Models Analysis