Trial Outcomes & Findings for A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation (NCT NCT00753298)
NCT ID: NCT00753298
Last Updated: 2021-11-11
Results Overview
Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
At 4 weeks
Results posted on
2021-11-11
Participant Flow
Participant milestones
| Measure |
LoFric Primo (POBE)
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
|
Overall Study
COMPLETED
|
89
|
94
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
Baseline characteristics by cohort
| Measure |
LoFric Primo (POBE)
n=97 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=98 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 16.16 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 17.20 • n=7 Participants
|
52 years
STANDARD_DEVIATION 16.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 weeksSubject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Outcome measures
| Measure |
LoFric Primo (POBE)
n=89 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=94 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Subject's Perception Regarding Handling of Test Catheter Before Insertion
|
1.71 Score on scale
Standard Deviation 1.13
|
1.76 Score on scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: At 4 weeksSubject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Outcome measures
| Measure |
LoFric Primo (POBE)
n=89 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=94 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Subject's Perception Regarding Handling of Test Catheter at Insertion
|
1.81 Score on scale
Standard Deviation 1.23
|
1.55 Score on scale
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: At 4 weeksSubject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Outcome measures
| Measure |
LoFric Primo (POBE)
n=89 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=94 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Subject's Perception Regarding Handling of Test Catheter at Withdrawal
|
1.55 Score on scale
Standard Deviation 0.93
|
1.44 Score on scale
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: At 4 weeksSubject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Outcome measures
| Measure |
LoFric Primo (POBE)
n=89 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=94 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Subject's Perception Regarding Handling of Test Catheter After Withdrawal
|
1.63 Score on scale
Standard Deviation 1.05
|
1.69 Score on scale
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: At 4 weeksSubject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)
Outcome measures
| Measure |
LoFric Primo (POBE)
n=89 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=94 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Subject's General Satisfaction With Test Catheter
|
2.01 Score on scale
Standard Deviation 0.99
|
1.75 Score on scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: At 4 weeksSubject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)
Outcome measures
| Measure |
LoFric Primo (POBE)
n=89 Participants
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=94 Participants
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Subject's Sensation When Using Test Catheter
|
1.86 Score on scale
Standard Deviation 0.90
|
1.91 Score on scale
Standard Deviation 0.92
|
Adverse Events
LoFric Primo (POBE)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
LoFric Primo (PVC)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LoFric Primo (POBE)
n=97 participants at risk
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=98 participants at risk
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Nervous system disorders
Hospitalization due to neurological problems
|
1.0%
1/97
|
0.00%
0/98
|
|
Blood and lymphatic system disorders
Sepsis due to Urinary Tract Infection
|
0.00%
0/97
|
1.0%
1/98
|
|
Nervous system disorders
Pseudotumor cerebri
|
1.0%
1/97
|
0.00%
0/98
|
Other adverse events
| Measure |
LoFric Primo (POBE)
n=97 participants at risk
LoFric Primo (POBE) single-use urinary catheter (Arm A)
|
LoFric Primo (PVC)
n=98 participants at risk
LoFric Primo (PVC) single-use urinary catheter (Arm B)
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
3.1%
3/97
|
7.1%
7/98
|
Additional Information
Head of Therapeutic Area Health Care
Astra Tech AB
Phone: +46317763000
Results disclosure agreements
- Principal investigator is a sponsor employee Astra Tech shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed in order for Astra Tech to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER