Trial Outcomes & Findings for Investigation of New Intermittent Catheters in Healthy Volunteers (NCT NCT04445051)

NCT ID: NCT04445051

Last Updated: 2023-07-03

Results Overview

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/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Immediately after the procedure/catheterization, up to 5 min.
• Results posted on: 2023-07-03

Participant Flow

Between March 2020 and September 2020, 30 users were recruited for the study from one site (Denmark) and encompassed the safety population.

The 30 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, one was discontinued after Visit 2 due to an adverse event. Two participants total had an adverse event, both were classified as mild, non-serious, 'Possibly related' and 'Not related' (for details; see Adverse Events section). Thus, 30 participants constituted the intention to treat (ITT) population.

Participant milestones

Measure	Comparator, Then Variant 2, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.	Variant 2, Then Variant 1, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Comparator, Then Variant 1, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Comparator, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Variant 2, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Variant 2, Then Comparator, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.
Overall Study STARTED	5	4	5	6	5	5
Overall Study COMPLETED	5	4	4	6	5	5
Overall Study NOT COMPLETED	0	0	1	0	0	0

Reasons for withdrawal

Measure	Comparator, Then Variant 2, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.	Variant 2, Then Variant 1, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Comparator, Then Variant 1, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Comparator, Then Variant 2 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.	Variant 1, Then Variant 2, Then Comparator On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.	Variant 2, Then Comparator, Then Variant 1 On three separate visits and in the listed random order, the participants underwent three interventions: First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.
Overall Study Adverse Event	0	0	1	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Female ITT Population n=15 Participants Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard female), the new Variant 1 female catheter, or the new Variant 2 female catheter.	Male ITT Population n=15 Participants Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard male), the new Variant 1 male catheter, or the new Variant 2 male catheter.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Continuous	31 years STANDARD_DEVIATION 12 • n=15 Participants	32 years STANDARD_DEVIATION 8 • n=15 Participants	32 years STANDARD_DEVIATION 10 • n=30 Participants
Sex: Female, Male Female	15 Participants n=15 Participants	0 Participants n=15 Participants	15 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	15 Participants n=15 Participants	15 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Denmark	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Hematuria positive	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Hematuria negative	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

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 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/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Residual Urine at 1st Flow-stop	35.0 mL Standard Deviation 71.0	1.1 mL Standard Deviation 2.6	0.2 mL Standard Deviation 0.7	37.0 mL Standard Deviation 40.0	2.2 mL Standard Deviation 6.2	1.0 mL Standard Deviation 4.0

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 15 min.

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 volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Post-void Residual Urine	8.6 mL Standard Deviation 11.4	1.5 mL Standard Deviation 6.1	27.6 mL Standard Deviation 104.1	5.3 mL Standard Deviation 8.9	24.3 mL Standard Deviation 79.1	16.3 mL Standard Deviation 31.9

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

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.

Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Catheterization Insertion Discomfort	0.51 cm Standard Deviation 0.72	0.81 cm Standard Deviation 0.96	0.86 cm Standard Deviation 1.15	2.32 cm Standard Deviation 2.24	2.31 cm Standard Deviation 1.97	2.79 cm Standard Deviation 2.46

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

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.

Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Catheterization Urination Discomfort	0.18 cm Standard Deviation 0.23	0.47 cm Standard Deviation 0.83	0.55 cm Standard Deviation 0.93	0.93 cm Standard Deviation 1.62	0.74 cm Standard Deviation 0.86	1.51 cm Standard Deviation 2.77

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

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.

Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Withdrawal Discomfort	0.79 cm Standard Deviation 0.70	0.83 cm Standard Deviation 0.94	1.11 cm Standard Deviation 1.32	2.05 cm Standard Deviation 2.55	1.42 cm Standard Deviation 1.86	2.28 cm Standard Deviation 2.39

SECONDARY outcome

Timeframe: Immediately after the procedure/catheterization, up to 5 min.

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.

Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Overall Catheterization Discomfort	0.66 cm Standard Deviation 0.65	0.72 cm Standard Deviation 0.63	1.04 cm Standard Deviation 1.63	1.99 cm Standard Deviation 2.19	1.71 cm Standard Deviation 1.57	2.58 cm Standard Deviation 2.56

SECONDARY outcome

Timeframe: Immediately after the first normal void following the procedure/catheterization, up to 5 min.

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.

Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

Outcome measures

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 Participants Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 Participants Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Post-catheterization Urination Discomfort	0.29 cm Standard Deviation 0.63	0.09 cm Standard Deviation 0.16	0.35 cm Standard Deviation 0.72	0.66 cm Standard Deviation 1.56	0.66 cm Standard Deviation 0.84	1.88 cm Standard Deviation 2.70

Adverse Events

Intermittent Catheter; SpeediCath® Standard Female

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Intermittent Catheter Variant 1 for Female

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Intermittent Catheter Variant 2 for Female

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermittent Catheter; SpeediCath® Standard Male

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

New Intermittent Catheter Variant 1 for Male

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

New Intermittent Catheter Variant 2 for Male

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intermittent Catheter; SpeediCath® Standard Female n=15 participants at risk Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Female n=15 participants at risk Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Female n=15 participants at risk Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.	Intermittent Catheter; SpeediCath® Standard Male n=15 participants at risk Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 1 for Male n=15 participants at risk Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.	New Intermittent Catheter Variant 2 for Male n=14 participants at risk Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.
Renal and urinary disorders Possibly related	0.00% 0/15 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/15 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/15 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/15 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	6.7% 1/15 • Number of events 1 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.	0.00% 0/14 • Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days. The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants. An adverse event was reported as either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the comparator to the Variant 1 or Variant 2 products.

Additional Information

Vice President, Medical Affairs

Coloplast A/S

Phone: +4549111111

Email: clinical-studies@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60