Trial Outcomes & Findings for A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization (NCT NCT00799981)
NCT ID: NCT00799981
Last Updated: 2021-05-18
Results Overview
Measurements were performed with the bladder scan BVI 3000. The primary outcome variable was average residual urine volume (mL) calculated from repetitive bladder scans performed after each catheterization. Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
Results posted on
2021-05-18
Participant Flow
Each subject eligible for entry into the study was a female using catheters for intermittent self catheterization at least once a day and had done so for the last month. Three centers in Sweden were involved. Four catheterizations, two with each product in a randomized order, were performed at the study centre. Catheterization should resemble the daily use as far as possible.
Participant milestones
| Measure |
AABB
7 cm then 7 cm then 10 cm then 10 cm
B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm
Four catheterizations, two with each product in a randomized order.
|
ABAB
7 cm then 10 cm then 7 cm then 10 cm
B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm
Four catheterizations, two with each product in a randomized order.
|
ABBA
7 cm then 10 cm then 10 cm then 7 cm
B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm
Four catheterizations, two with each product in a randomized order.
|
BAAB
10 cm then 7 cm then 7 cm then 10 cm
B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm
Four catheterizations, two with each product in a randomized order.
|
BABA
10 cm then 7 cm then 10 cm then 7 cm
B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm
Four catheterizations, two with each product in a randomized order.
|
BBAA
10 cm then 10 cm then 7 cm then 7 cm
B=Astra Tech POBE catheter, 10 cm A=Coloplast SpeediCath Compact catheter, 7 cm
Four catheterizations, two with each product in a randomized order.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
10
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
10
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
Baseline characteristics by cohort
| Measure |
Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order
n=60 Participants
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 6 arms with the following order of catheters used: AABB ABAB ABBA BAAB BABA BBAA BBAA
|
|---|---|
|
Age, Continuous
|
48.20 years
STANDARD_DEVIATION 15.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
60 participants
n=5 Participants
|
|
Weight
|
66.53 Kilogramme
STANDARD_DEVIATION 13.98 • n=5 Participants
|
|
Height
|
163.62 Cm
STANDARD_DEVIATION 7.48 • n=5 Participants
|
|
BMI
|
24.78 kg/m^2
STANDARD_DEVIATION 4.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.Population: All subjects in the investigation
Measurements were performed with the bladder scan BVI 3000. The primary outcome variable was average residual urine volume (mL) calculated from repetitive bladder scans performed after each catheterization. Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated.
Outcome measures
| Measure |
7 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
10 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
|---|---|---|
|
Bladder Scan Measurements of Residual Urine Volume
|
32.74 Residual volume in mL
Standard Deviation 41.48
|
34.78 Residual volume in mL
Standard Deviation 38.76
|
SECONDARY outcome
Timeframe: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.Population: All subjects participating in the investigation.
Outcome measures
| Measure |
7 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
10 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
|---|---|---|
|
Number of Subjects With a Residual Volume >5mL or ≤5mL
> 5 mL
|
42 Participants
|
40 Participants
|
|
Number of Subjects With a Residual Volume >5mL or ≤5mL
≤ 5 mL
|
18 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.Population: All subjecs participating in the investigation.
Outcome measures
| Measure |
7 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
10 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
|---|---|---|
|
Number of Subjects With a Residual Volume >10mL or ≤10mL
>10mL
|
38 Participants
|
37 Participants
|
|
Number of Subjects With a Residual Volume >10mL or ≤10mL
≤10mL
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.Population: All subjects in the investigation.
Outcome measures
| Measure |
7 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
10 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
|---|---|---|
|
Number of Subjects With a Residual Volume >30mL or ≤30mL
>30mL
|
19 Participants
|
26 Participants
|
|
Number of Subjects With a Residual Volume >30mL or ≤30mL
≤30mL
|
41 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.Population: All subjects participating in the investigation.
Outcome measures
| Measure |
7 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
10 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
|---|---|---|
|
Number of Subjects With a Residual Volume >50mL or ≤50mL
>50mL
|
15 Participants
|
16 Participants
|
|
Number of Subjects With a Residual Volume >50mL or ≤50mL
≤50mL
|
45 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Question asked minutes after catheterization.Population: All subjects participating in the investigation.
After each catheterization the study nurse will ask the subject whether it feels as if the bladder is completely emptied or not. 0=No and 1=Yes.
Outcome measures
| Measure |
7 cm
n=60 Participants
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
10 cm
All study participants were catheterizised with both catheters twice in a randomized order.
Every subject is its' own control.
|
|---|---|---|
|
Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
7 cm
|
0.75 score on a scale
Standard Deviation 0.40
|
—
|
|
Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
10 cm
|
0.83 score on a scale
Standard Deviation 0.35
|
—
|
|
Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
7 cm - 10 cm
|
-0.08 score on a scale
Standard Deviation 0.26
|
—
|
Adverse Events
7 cm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10 cm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
7 cm
n=60 participants at risk
Coloplast SpeediCath Compact catheter, 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
|
10 cm
n=60 participants at risk
Astra Tech POBE catheter, 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
|
|---|---|---|
|
Renal and urinary disorders
Burning sensation in urethra one hour after catheterization
|
0.00%
0/60 • The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.
The term adverse events will be used together with the term adverse device effects in this system due to limitations in choise in reporting.
|
1.7%
1/60 • Number of events 1 • The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.
The term adverse events will be used together with the term adverse device effects in this system due to limitations in choise in reporting.
|
|
Reproductive system and breast disorders
Menstrual bleeding
|
1.7%
1/60 • Number of events 1 • The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.
The term adverse events will be used together with the term adverse device effects in this system due to limitations in choise in reporting.
|
0.00%
0/60 • The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.
The term adverse events will be used together with the term adverse device effects in this system due to limitations in choise in reporting.
|
|
General disorders
Headache
|
1.7%
1/60 • Number of events 1 • The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.
The term adverse events will be used together with the term adverse device effects in this system due to limitations in choise in reporting.
|
0.00%
0/60 • The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.
The term adverse events will be used together with the term adverse device effects in this system due to limitations in choise in reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place