Urinary Incontinence
Conditions
Brief summary
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.
Interventions
DEVICEInvestigational 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.
DEVICEComparator device
Hollister Infyna Chic, single-use compact catheter.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
controlled crossover study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is Female * Is at least 18 years of age and has full legal capacity * Has signed an informed consent form * Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion * Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying * Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study * Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator
Exclusion criteria
* Is participating in any other clinical study during this investigation * Has previously participated in this study * Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id) * Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris * Has any known allergies towards ingredients in the investigational device * Is pregnant * Is breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | At Visit 1 and Visit 2 | Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, \[mL\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Flowstops (Catheterisation Performed by a Healthcare Professional) | At Visit 1 and Visit 2 | Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), \[number\]. |
| Residual Volume Post Catheterisation | At Visit 1 and Visit 2 | Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), \[mL\], |
| Number of Adverse Events | At Visit 1 and Visit 2 | Count number of Adverse events, \[number\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Measure by VAS (Only in DK) | At Visit 1 and Visit 2 | 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, \[cm\] |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | Total ITT Population Baseline Measures | — |
|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 13.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 57 participants | — |
| Region of Enrollment United Kingdom | 16 participants | — |
| Sex: Female, Male Female | 73 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 72 |
| other Total, other adverse events | 1 / 73 | 1 / 72 |
| serious Total, serious adverse events | 0 / 73 | 0 / 72 |
Outcome results
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, \[mL\]
Time frame: At Visit 1 and Visit 2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | 15.3 mL |
| Hollister Infyna Chic | Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP) | 23.7 mL |
Secondary
Number of Adverse Events
Count number of Adverse events, \[number\]
Time frame: At Visit 1 and Visit 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Number of Adverse Events | 1 Adverse events |
| Hollister Infyna Chic | Number of Adverse Events | 1 Adverse events |
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), \[number\].
Time frame: At Visit 1 and Visit 2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Number of Flowstops (Catheterisation Performed by a Healthcare Professional) | 0.27 Number of flow-stops |
| Hollister Infyna Chic | Number of Flowstops (Catheterisation Performed by a Healthcare Professional) | 0.59 Number of flow-stops |
Secondary
Residual Volume Post Catheterisation
Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), \[mL\],
Time frame: At Visit 1 and Visit 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Residual Volume Post Catheterisation | 10.1 mL | Standard Deviation 34.1 |
| Hollister Infyna Chic | Residual Volume Post Catheterisation | 15.8 mL | Standard Deviation 51 |
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, \[cm\]
Time frame: At Visit 1 and Visit 2
Population: This analysis was only performed with the investigational device and only on the participants from sites in Denmark.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Discomfort Measure by VAS (Only in DK) | Discomfort at insertion | 0.19 score on a scale | Standard Deviation 0.51 |
| Investigational Device - Newly Developed Intermittent Compact Catheter | Discomfort Measure by VAS (Only in DK) | Discomfort at withdrawal | 0.24 score on a scale | Standard Deviation 1.02 |
| Investigational Device - Newly Developed Intermittent Compact Catheter | Discomfort Measure by VAS (Only in DK) | Discomfort by completion | 0.21 score on a scale | Standard Deviation 0.62 |
| Investigational Device - Newly Developed Intermittent Compact Catheter | Discomfort Measure by VAS (Only in DK) | Discomfort when emptying | 0.19 score on a scale | Standard Deviation 0.76 |
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.
Time frame: At Visit 1 and Visit 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Response to Treatment, 0 Flow-stops | 87 percentage of catheterisations |
| Hollister Infyna Chic | Response to Treatment, 0 Flow-stops | 61 percentage of catheterisations |
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.
Time frame: At Visit 1 and Visit 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device - Newly Developed Intermittent Compact Catheter | Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter | 84 percentage of catheterisations |
| Hollister Infyna Chic | Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter | 68 percentage of catheterisations |