Trial Outcomes & Findings for Quality of Life Intermittent Catheter Study (NCT NCT01523743)
NCT ID: NCT01523743
Last Updated: 2016-09-30
Results Overview
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
125 participants
Primary outcome timeframe
6 weeks
Results posted on
2016-09-30
Participant Flow
Participant milestones
| Measure |
First Compact Catheter, Then Standard Care
First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
|
First Standard Care; Then Compact Catheter
First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
|
|---|---|---|
|
Period 1
STARTED
|
63
|
62
|
|
Period 1
COMPLETED
|
53
|
60
|
|
Period 1
NOT COMPLETED
|
10
|
2
|
|
Period 2
STARTED
|
53
|
60
|
|
Period 2
COMPLETED
|
52
|
58
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
First Compact Catheter, Then Standard Care
First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
|
First Standard Care; Then Compact Catheter
First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
6
|
2
|
|
Period 1
Lost to Follow-up
|
1
|
0
|
|
Period 1
Lack of Efficacy
|
1
|
0
|
|
Period 1
Felt unable to empty bladder
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
2
|
|
Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
Quality of Life Intermittent Catheter Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=118 Participants
125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.
The baseline and analysis data are based on the ITT population.
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 15.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=99 Participants
|
|
Region of Enrollment
France
|
40 participants
n=99 Participants
|
|
Region of Enrollment
Denmark
|
27 participants
n=99 Participants
|
|
Region of Enrollment
Norway
|
5 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=99 Participants
|
|
Region of Enrollment
Sweden
|
28 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products.
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.
Outcome measures
| Measure |
Compact Catheter
n=112 Participants
Compact intermittent catheter
|
Standard Care
n=114 Participants
Standard Care: Coated intermittent catheter normally used by subject
|
|---|---|---|
|
Quality of Life (0-100 Point)
|
76.8 units on a scale
Standard Deviation 14.5
|
59.8 units on a scale
Standard Deviation 19.3
|
Adverse Events
Compact Catheter
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Standard Care
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Compact Catheter
n=123 participants at risk
Compact intermittent catheter
|
Standard Care
n=115 participants at risk
Standard Care: Coated intermittent catheter normally used by subject
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Neuropathic pain
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Pneumopathy
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
Other adverse events
| Measure |
Compact Catheter
n=123 participants at risk
Compact intermittent catheter
|
Standard Care
n=115 participants at risk
Standard Care: Coated intermittent catheter normally used by subject
|
|---|---|---|
|
Infections and infestations
Influenza
|
0.81%
1/123 • Number of events 1
|
0.87%
1/115 • Number of events 1
|
|
Renal and urinary disorders
Kidney Stone
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.81%
1/123 • Number of events 2
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
UTI
|
1.6%
2/123 • Number of events 2
|
4.3%
5/115 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Cold
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Nervous system disorders
Neuropathic pain
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Anal hemorrhoids
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Surgical and medical procedures
Planned plastic surgery of ulcer
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Surgical and medical procedures
Urethral sensitivity when Catheter removed
|
1.6%
2/123 • Number of events 2
|
0.00%
0/115
|
|
Renal and urinary disorders
Haematuria
|
1.6%
2/123 • Number of events 2
|
0.00%
0/115
|
|
Musculoskeletal and connective tissue disorders
Pain in hands
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Infections and infestations
Abscess tooth and gingival
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Nervous system disorders
Insomnia
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Skin and subcutaneous tissue disorders
Ischial pressure ulcer
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Tendinophaty
|
0.00%
0/123
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Skin herpes
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
|
Nervous system disorders
Spasticity of legs
|
0.81%
1/123 • Number of events 1
|
0.00%
0/115
|
Additional Information
Pref. Emmanuel Chartier-kastler
Hopital Raymond poincare
Phone: +33 1 42 17 71 29
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60