Trial Outcomes & Findings for Clinical Trial of New Single-use Compact Intermittent Catheter (NCT NCT05841004)
NCT ID: NCT05841004
Last Updated: 2025-01-23
Results Overview
Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, \[mL\]
COMPLETED
NA
73 participants
At Visit 1 and Visit 2
2025-01-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (Visit 1)
STARTED
|
37
|
36
|
|
First Intervention (Visit 1)
COMPLETED
|
36
|
36
|
|
First Intervention (Visit 1)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (Visit 2)
STARTED
|
36
|
36
|
|
Second Intervention (Visit 2)
COMPLETED
|
36
|
36
|
|
Second Intervention (Visit 2)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total ITT Population Baseline Measures
n=73 Participants
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
|
|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 13.1 • n=73 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=73 Participants
|
|
Region of Enrollment
Denmark
|
57 participants
n=73 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=73 Participants
|
PRIMARY outcome
Timeframe: At Visit 1 and Visit 2Measure residual volume at 1st flow-stop i.e., post catheterisation volume minus volume at 1st flow-stop, both derived from a catheterisation profile, \[mL\]
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=72 Participants
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.
|
Hollister Infyna Chic
n=72 Participants
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.
|
|---|---|---|
|
Residual Volume at 1st Flow-stop (Catheterisation Performed by HCP)
|
15.3 mL
Interval 3.7 to 26.9
|
23.7 mL
Interval 10.8 to 37.0
|
SECONDARY outcome
Timeframe: At Visit 1 and Visit 2Measure number of flow-stop episodes derived from a catheterisation profile (catheterisation performed by a healthcare professional), \[number\].
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=72 Participants
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.
|
Hollister Infyna Chic
n=72 Participants
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.
|
|---|---|---|
|
Number of Flowstops (Catheterisation Performed by a Healthcare Professional)
|
0.27 Number of flow-stops
Interval 0.13 to 0.55
|
0.59 Number of flow-stops
Interval 0.36 to 0.96
|
SECONDARY outcome
Timeframe: At Visit 1 and Visit 2Measure average residual volume post catheterisation (PVR) measured with a bladder scanner (triplicate measurements), \[mL\],
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=72 Participants
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.
|
Hollister Infyna Chic
n=72 Participants
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.
|
|---|---|---|
|
Residual Volume Post Catheterisation
|
10.1 mL
Standard Deviation 34.1
|
15.8 mL
Standard Deviation 51.0
|
SECONDARY outcome
Timeframe: At Visit 1 and Visit 2Count number of Adverse events, \[number\]
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=72 Participants
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.
|
Hollister Infyna Chic
n=72 Participants
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.
|
|---|---|---|
|
Number of Adverse Events
|
1 Adverse events
|
1 Adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 1 and Visit 2Population: This analysis was only performed with the investigational device and only on the participants from sites in Denmark.
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, \[cm\]
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=54 Participants
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.
|
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.
|
|---|---|---|
|
Discomfort Measure by VAS (Only in DK)
Discomfort at insertion
|
0.19 score on a scale
Standard Deviation 0.51
|
—
|
|
Discomfort Measure by VAS (Only in DK)
Discomfort at withdrawal
|
0.24 score on a scale
Standard Deviation 1.02
|
—
|
|
Discomfort Measure by VAS (Only in DK)
Discomfort by completion
|
0.21 score on a scale
Standard Deviation 0.62
|
—
|
|
Discomfort Measure by VAS (Only in DK)
Discomfort when emptying
|
0.19 score on a scale
Standard Deviation 0.76
|
—
|
POST_HOC outcome
Timeframe: At Visit 1 and Visit 2Responder 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.
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=72 Participants
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.
|
Hollister Infyna Chic
n=72 Participants
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.
|
|---|---|---|
|
Response to Treatment, Residual Volume of Urine at First Flow-stop Under 10 Milliliter
|
84 percentage of catheterisations
Interval 72.0 to 91.0
|
68 percentage of catheterisations
Interval 56.0 to 79.0
|
POST_HOC outcome
Timeframe: At Visit 1 and Visit 2Responder 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.
Outcome measures
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=72 Participants
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.
|
Hollister Infyna Chic
n=72 Participants
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.
|
|---|---|---|
|
Response to Treatment, 0 Flow-stops
|
87 percentage of catheterisations
Interval 76.0 to 93.0
|
61 percentage of catheterisations
Interval 48.0 to 72.0
|
Adverse Events
Investigational Device - Newly Developed Intermittent Compact Catheter
Hollister Infyna Chic
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational Device - Newly Developed Intermittent Compact Catheter
n=73 participants at risk
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.
|
Hollister Infyna Chic
n=72 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Obstipation
|
0.00%
0/73 • 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).
|
1.4%
1/72 • Number of events 1 • 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).
|
|
Renal and urinary disorders
Pain when urinating
|
1.4%
1/73 • Number of events 1 • 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).
|
0.00%
0/72 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60