Trial Outcomes & Findings for Evaluation of Residual Urine After Intermittent Catheterisation (NCT NCT00324233)
NCT ID: NCT00324233
Last Updated: 2013-01-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
2
Results posted on
2013-01-01
Participant Flow
Participant milestones
| Measure |
SC Then SCCM
SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
|
SCCM Then SC
SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
|
|---|---|---|
|
First Period
STARTED
|
18
|
18
|
|
First Period
COMPLETED
|
17
|
18
|
|
First Period
NOT COMPLETED
|
1
|
0
|
|
Second Period
STARTED
|
17
|
18
|
|
Second Period
COMPLETED
|
12
|
11
|
|
Second Period
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
SC Then SCCM
SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
|
SCCM Then SC
SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
|
|---|---|---|
|
First Period
unable to insert catheter
|
1
|
0
|
|
Second Period
unable to insert catheter
|
1
|
1
|
|
Second Period
Protocol Violation
|
4
|
6
|
Baseline Characteristics
Evaluation of Residual Urine After Intermittent Catheterisation
Baseline characteristics by cohort
| Measure |
SC Then SCCM
n=18 Participants
SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
|
SCCM Then SC
n=18 Participants
SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
|
Total
n=36 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
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
23.6 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
23.7 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2Outcome measures
| Measure |
SpeediCath
n=36 Participants
|
SpediCath Compact Male
n=33 Participants
|
|---|---|---|
|
Residual Urine Measured by Ultra Sound
|
11 ml
Standard Deviation 30
|
6 ml
Standard Deviation 23
|
SECONDARY outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Outcome measures
Outcome data not reported
Adverse Events
SC Then SCCM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SCCM Then SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60