Trial Outcomes & Findings for Evaluation of a New Catheter Material for Intermittent Catheterization (NCT NCT01295281)

NCT ID: NCT01295281

Last Updated: 2021-11-11

Results Overview

The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

107 participants

Primary outcome timeframe

At 7 and 14 days after randomization, respectively

Results posted on

2021-11-11

Participant Flow

107 subjects were enrolled in the study but 105 started treatment, i.e. two subjects dropped out before start of treatment. Both these subjects missed to fulfil all inclusion criteria. 53 subjects started using LoFric Polyolefin Based Elastomer (POBE) 2.0 and 52 subjects started using LoFric Polyvinyl Chloride (PVC).

Participant milestones

Participant milestones
Measure	LoFric POBE 2.0 - PVC First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.	LoFric PVC - POBE 2.0 First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0. LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
First Intervention (7 Days) STARTED	53	52
First Intervention (7 Days) COMPLETED	53	51
First Intervention (7 Days) NOT COMPLETED	0	1
Second Intervention (7days) STARTED	53	51
Second Intervention (7days) COMPLETED	53	51
Second Intervention (7days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LoFric POBE 2.0 - PVC First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.	LoFric PVC - POBE 2.0 First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0. LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
First Intervention (7 Days) Death	0	1

Baseline Characteristics

Evaluation of a New Catheter Material for Intermittent Catheterization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LoFric POBE 2.0 - PVC n=53 Participants First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.	LoFric PVC - POBE 2.0 n=52 Participants First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0. LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.	Total n=105 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 10 • n=93 Participants	72 years STANDARD_DEVIATION 10 • n=4 Participants	72 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	53 Participants n=93 Participants	52 Participants n=4 Participants	105 Participants n=27 Participants
Region of Enrollment Sweden	53 participants n=93 Participants	52 participants n=4 Participants	105 participants n=27 Participants

PRIMARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

Population: Since the study is cross-over, all (104) subjects evaluated both LoFric POBE 2.0 and LoFric PVC. To be able to group and describe the results the "Arm/Group Titles" are renamed in this section to "LoFric POBE 2.0" and "LoFric PVC" respectively. Each Arm/Group describing the outcome for all 104 subjects (ITT analysis set).

The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.

Outcome measures

Outcome measures
Measure	LoFric POBE 2.0 n=104 Participants Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.	LoFric PVC n=104 Participants Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
Number of Participants With Discomfort	15 participants	29 participants

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To compare subject's tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To compare subject's tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To compare subject's tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To compare subject's tolerability with regards to perceived "other discomfort", when using two different urinary catheters; PVC vs. POBE 2.0. Frequency of "other discomfort" (yes/ no) will be assessed in patient questionnaire. The frequency of "other discomfort" will be compared between the treatments. "Other discomfort" will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To evaluate subject perception related to the properties of the catheter's coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 7 and 14 days after randomization, respectively

To compare subject's tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).

Outcome measures

Outcome data not reported

Adverse Events

LoFric POBE 2.0

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

LoFric PVC

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LoFric POBE 2.0 n=104 participants at risk Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.	LoFric PVC n=105 participants at risk Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
Vascular disorders Stroke	0.00% 0/104 • From signing of Informed Consent until End of Study, up to 14 days.	0.95% 1/105 • Number of events 1 • From signing of Informed Consent until End of Study, up to 14 days.
Surgical and medical procedures Abnormal potassium level during planned cytostatic treatment	0.96% 1/104 • Number of events 1 • From signing of Informed Consent until End of Study, up to 14 days.	0.00% 0/105 • From signing of Informed Consent until End of Study, up to 14 days.
Injury, poisoning and procedural complications Snakebite	0.00% 0/104 • From signing of Informed Consent until End of Study, up to 14 days.	0.95% 1/105 • Number of events 1 • From signing of Informed Consent until End of Study, up to 14 days.

Other adverse events

Other adverse events
Measure	LoFric POBE 2.0 n=104 participants at risk Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.	LoFric PVC n=105 participants at risk Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
Renal and urinary disorders Bleeding in connection to catheterization	2.9% 3/104 • From signing of Informed Consent until End of Study, up to 14 days.	6.7% 7/105 • From signing of Informed Consent until End of Study, up to 14 days.
Renal and urinary disorders Burning sensation in connection to catheterization	10.6% 11/104 • From signing of Informed Consent until End of Study, up to 14 days.	20.0% 21/105 • From signing of Informed Consent until End of Study, up to 14 days.
Renal and urinary disorders Pain in connection to catheterization	13.5% 14/104 • From signing of Informed Consent until End of Study, up to 14 days.	20.0% 21/105 • From signing of Informed Consent until End of Study, up to 14 days.

Additional Information

Dikran Shamoun

Wellspect HealthCare

Phone: +46313764275

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60