Trial Outcomes & Findings for Performance of a Single-use Intermittent Micro-hole Zone Catheter (NCT NCT05485922)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Immediately after the procedure/catheterization

Results posted on

2025-03-05

Participant Flow

Between August 2022 and November 2022, 42 users were recruited for the study from one site (Denmark) and encompassed the safety population.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Visit 1 STARTED	21	21
Visit 1 COMPLETED	21	21
Visit 1 NOT COMPLETED	0	0
Visit 2 STARTED	21	21
Visit 2 Intention to Treat	21	21
Visit 2 COMPLETED	21	21
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

Baseline characteristics by cohort
Measure	Total ITT Population Baseline Measures n=42 Participants 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.
Age, Categorical <=18 years	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=42 Participants
Age, Categorical >=65 years	28 Participants n=42 Participants
Age, Continuous	68 years n=42 Participants
Sex: Female, Male Female	0 Participants n=42 Participants
Sex: Female, Male Male	42 Participants n=42 Participants
Region of Enrollment Denmark	42 participants n=42 Participants
Number of participants with neurogenic bladder dysfunction	13 Participants n=42 Participants
Number of participants with non-neurogenic bladder dysfunction	29 Participants n=42 Participants

PRIMARY outcome

Timeframe: Immediately after the procedure/catheterization

Population: The full analysis set

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.

Outcome measures

Outcome measures
Measure	Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) n=41 Participants A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage. The external diameter is measured in millimeters (Charrière scale: Ch, CH) which were available in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Investigational 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.	Comparator Device - VaPro Intermittent Catheter n=42 Participants 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.
Number of Flow-stop Episodes	0.17 Flow stop episodes Interval 0.06 to 0.45	1.09 Flow stop episodes Interval 0.75 to 1.6

PRIMARY outcome

Timeframe: 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.

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 \[g\].

Outcome measures

Outcome measures
Measure	Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) n=42 Participants A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage. The external diameter is measured in millimeters (Charrière scale: Ch, CH) which were available in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Investigational 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.	Comparator Device - VaPro Intermittent Catheter n=42 Participants 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.
Residual Urine at 1st Flow-stop	5.10 mL Interval 2.79 to 7.42	39.40 mL Interval 19.92 to 58.89

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) n=42 Participants A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage. The external diameter is measured in millimeters (Charrière scale: Ch, CH) which were available in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Investigational 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.	Comparator Device - VaPro Intermittent Catheter n=42 Participants 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.
Number of Flow-stop Episodes	0.17 Flow stop episodes Interval 0.06 to 0.45	1.09 Flow stop episodes Interval 0.75 to 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

The intra-catheter pressure at the drainage holes, measured at 1st flow stop, was identified from a sensor curve.

Outcome measures

Outcome measures
Measure	Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) n=42 Participants A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage. The external diameter is measured in millimeters (Charrière scale: Ch, CH) which were available in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Investigational 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.	Comparator Device - VaPro Intermittent Catheter n=42 Participants 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.
Pressure Measurement at 1st Flow-stop Derived From a Catheterisation Profile.	-16.14 mbar Interval -22.5 to -9.79	-111.83 mbar Interval -153.4 to -70.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Post-catheterisation volume measured with a bladder Scanner assessed by the average of 3 consecutive measurements \[mL\]

Outcome measures

Outcome measures
Measure	Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) n=42 Participants A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage. The external diameter is measured in millimeters (Charrière scale: Ch, CH) which were available in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Investigational 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.	Comparator Device - VaPro Intermittent Catheter n=42 Participants 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.
Post-catheterisation Volume	5.92 mL Interval -2.17 to 14.01	7.13 mL Interval -2.39 to 16.64

POST_HOC outcome

Timeframe: 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.

Haematuria measured with a dipstick in the catheterised urine

Outcome measures

Outcome measures
Measure	Investigational Device - Intermittent Catheter With a Micro-hole Zone (MHZ) n=42 Participants A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage. The external diameter is measured in millimeters (Charrière scale: Ch, CH) which were available in sizes CH12 and CH14. The catheterization was performed by a trained nurse. Investigational 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.	Comparator Device - VaPro Intermittent Catheter n=42 Participants 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.
Probability of a Positive Test for Hematuria	0.10 probability of positive test Interval 0.03 to 0.24	0.29 probability of positive test Interval 0.17 to 0.45

Adverse Events

Investigational Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Writer

Coloplast, Clinical strategies

Phone: +4549112057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60