Trial Outcomes & Findings for A Confirmatory Study Confirming Performance of a New Intermittent Catheter (NCT NCT05485935)

Last Updated: 2025-03-18

Results Overview

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 \[g\].

Recruitment status

COMPLETED

Study phase

Target enrollment

73 participants

Primary outcome timeframe

Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization

Results posted on

2025-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Period 1 (V0, V1, T1, and V2) STARTED	36	37
Period 1 (V0, V1, T1, and V2) COMPLETED	32	36
Period 1 (V0, V1, T1, and V2) NOT COMPLETED	4	1
Period 1 (V2 Subpopulation) STARTED	23	26
Period 1 (V2 Subpopulation) COMPLETED	23	26
Period 1 (V2 Subpopulation) NOT COMPLETED	0	0
Period 2 (T2 and V3) STARTED	32	36
Period 2 (T2 and V3) COMPLETED	32	34
Period 2 (T2 and V3) NOT COMPLETED	0	2
Period 2 (V3 Subpopulation) STARTED	23	26
Period 2 (V3 Subpopulation) COMPLETED	23	26
Period 2 (V3 Subpopulation) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Period 1 (V0, V1, T1, and V2) Adverse Event	1	1
Period 1 (V0, V1, T1, and V2) Withdrawal by Subject	3	0
Period 2 (T2 and V3) Adverse Event	0	1
Period 2 (T2 and V3) loss of contact	0	1

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=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 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
Age, Continuous	63.9 years STANDARD_DEVIATION 13.9 • n=73 Participants
Sex: Female, Male Female	0 Participants n=73 Participants
Sex: Female, Male Male	73 Participants n=73 Participants
Region of Enrollment Denmark	46 participants n=73 Participants
Region of Enrollment United Kingdom	13 participants n=73 Participants
Region of Enrollment France	6 participants n=73 Participants
Region of Enrollment Germany	8 participants n=73 Participants
Number of participants with neurogenic bladder dysfunction	28 Participants n=73 Participants
Number of participants with non-neurogenic bladder dysfunction	45 Participants n=73 Participants

PRIMARY outcome

Timeframe: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization

Population: 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.

Outcome measures

Outcome measures
Measure	Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) n=49 Participants 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.	Comparator Device (Standard Intermittent Catheter, CH12/14) n=49 Participants 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.
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	18 mL Interval 7.05 to 28.94	63.93 mL Interval 37.86 to 90.01

PRIMARY outcome

Timeframe: Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) n=49 Participants 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.	Comparator Device (Standard Intermittent Catheter, CH12/14) n=49 Participants 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.
Number of Flow-stop Episodes (HCP-led Catheterization)	0.20 Flow stop episodes Interval 0.09 to 0.43	1.32 Flow stop episodes Interval 0.96 to 1.8

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) n=49 Participants 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.	Comparator Device (Standard Intermittent Catheter, CH12/14) n=49 Participants 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.
Number of Flow-stop Episodes (Self-led Catheterization)	0.13 Flow stop episodes Interval 0.04 to 0.37	0.96 Flow stop episodes Interval 0.65 to 1.43

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home 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 \[g\].

Outcome measures

Outcome measures
Measure	Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) n=49 Participants 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.	Comparator Device (Standard Intermittent Catheter, CH12/14) n=49 Participants 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.
Residual Urine at 1st Flow Stop (Self-led Catheterization)	8.2 mL Interval -5.6 to 22.1	36.8 mL Interval 23.1 to 50.05

SECONDARY outcome

Timeframe: 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).

Population: Participants from the full analysis set during the first and second home period (FAS1)

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 \[Erythrocytes/µL\].

Outcome measures

Outcome measures
Measure	Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) n=66 Participants 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.	Comparator Device (Standard Intermittent Catheter, CH12/14) n=66 Participants 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.
Mean Red Blood Cell Concentration	16.25 erythrocytes per microliter Interval 6.69 to 25.81	19.77 erythrocytes per microliter Interval 10.2 to 29.33

SECONDARY outcome

Timeframe: week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).

Population: Participants from the full analysis set during the first and second home period, (FAS1).

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.

Outcome measures

Outcome measures
Measure	Investigational Device (Intermittent Catheter With Micro-hole Zone, CH12 or CH14) n=66 Participants 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.	Comparator Device (Standard Intermittent Catheter, CH12/14) n=66 Participants 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.
Positive Hematuria Event Post-catheterisation	0.17 positive hematuria events Interval 0.14 to 0.19	0.19 positive hematuria events Interval 0.17 to 0.22

Adverse Events

Investigational Device

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Comparator Device

Serious events: 0 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Device n=73 participants at risk 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.	Comparator Device n=73 participants at risk 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.
Cardiac disorders Cardiac arrest	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
Renal and urinary disorders Urosepsis	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
Endocrine disorders unbalanced type 2 diabetes	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.

Other adverse events

Other adverse events
Measure	Investigational Device n=73 participants at risk 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.	Comparator Device n=73 participants at risk 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.
Renal and urinary disorders Urinary tract infection	2.7% 2/73 • Number of events 2 • 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.	2.7% 2/73 • Number of events 2 • 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.
Infections and infestations Fever	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
Respiratory, thoracic and mediastinal disorders Infection	0.00% 0/73 • 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.	1.4% 1/73 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/73 • 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.	1.4% 1/73 • Number of events 1 • 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.
Renal and urinary disorders Urolithiasis	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
Skin and subcutaneous tissue disorders Epididymit	0.00% 0/73 • 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.	1.4% 1/73 • Number of events 1 • 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.
Renal and urinary disorders Blood in urine	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
Infections and infestations Gout	0.00% 0/73 • 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.	1.4% 1/73 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Swollen foot	0.00% 0/73 • 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.	1.4% 1/73 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders fracture	0.00% 0/73 • 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.	1.4% 1/73 • Number of events 1 • 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.
Renal and urinary disorders Stinging in urethra	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
General disorders Fatigue	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.
Renal and urinary disorders Micturition	1.4% 1/73 • Number of events 1 • 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.	0.00% 0/73 • 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.

Additional Information

Malene Hornbak Landauro, Medical writer of Clinical strategies

Coloplast A/S

Phone: +4549112057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60