Catheterization
Conditions
Brief summary
A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermittent catheterization.
Detailed description
The study personnel will conduct three bladder scans after each catheterization in order to obtain the mean residual urine volume. Each patient will catheterize herself two times with each product, i.e. a total of four catheterizations. Diagnosis and BMI will be collected at visit 1 to assess whether the residual urine volume differs between these subgroups. The hypothesis that the mean residual volumes were equal when using the 7 and the 10 centimeter catheters was tested by means of the Wilcoxon signed rank test.
Interventions
DEVICEA=SpeediCath Compact 7 cm and B=POBE 10 cm
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The subjects were handed out numbered boxes with the catheter randomised to be used and then cathererisized by herself. The investigator was blinded to which catheter was used.
Intervention model description
The study was designed as a randomised, single blind, cross-over study to eliminate bias. Every subject was catheterisized with both 7 cm and 10 cm long catheters.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed informed consent * Female subjects aged 18 years and over * Experienced users of CIC with a minimum of one month of use * Practice CIC a minimum of 1 time per day * Practice CIC with female catheters with a maximum length of 20 cm * Perform self-catheterization * Sufficient hand function to be able to open and handle catheter packages * Use catheters with Ch 10, 12 or 14
Exclusion criteria
* Pregnancy * Ongoing symptomatic UTI * Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site) * Previous enrolment or randomisation of treatment in the present study * Participation in another clinical study during the study period * Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder Scan Measurements of Residual Urine Volume | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Residual Volume >5mL or ≤5mL | 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. | — |
| Number of Subjects With a Residual Volume >10mL or ≤10mL | 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. | — |
| Number of Subjects With a Residual Volume >30mL or ≤30mL | 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. | — |
| Number of Subjects With a Residual Volume >50mL or ≤50mL | 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. | — |
| Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects) | Question asked minutes after catheterization. | 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. |
Countries
Sweden
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order 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 | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Age, Continuous | 48.20 years STANDARD_DEVIATION 15.34 |
| BMI | 24.78 kg/m^2 STANDARD_DEVIATION 4.52 |
| Height | 163.62 Cm STANDARD_DEVIATION 7.48 |
| Region of Enrollment Sweden | 60 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 66.53 Kilogramme STANDARD_DEVIATION 13.98 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 2 / 60 | 1 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Bladder Scan Measurements of Residual Urine Volume
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 7 cm | Bladder Scan Measurements of Residual Urine Volume | 32.74 Residual volume in mL | Standard Deviation 41.48 |
| 10 cm | Bladder Scan Measurements of Residual Urine Volume | 34.78 Residual volume in mL | Standard Deviation 38.76 |
Comparison: The hypothesis that a 10 cm catheter provides equal emptying of the bladder as a 7 cm catheter was tested.p-value: 0.8762Wilcoxon (Mann-Whitney)
Secondary
Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
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.
Time frame: Question asked minutes after catheterization.
Population: All subjects participating in the investigation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 7 cm | Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects) | 7 cm | 0.75 score on a scale | Standard Deviation 0.4 |
| 7 cm | Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects) | 10 cm | 0.83 score on a scale | Standard Deviation 0.35 |
| 7 cm | 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 |
Comparison: In the table 0=No and 1=Yes.p-value: 0.0273Wilcoxon (Mann-Whitney)
Secondary
Number of Subjects With a Residual Volume >10mL or ≤10mL
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7 cm | Number of Subjects With a Residual Volume >10mL or ≤10mL | >10mL | 38 Participants |
| 7 cm | Number of Subjects With a Residual Volume >10mL or ≤10mL | ≤10mL | 22 Participants |
| 10 cm | Number of Subjects With a Residual Volume >10mL or ≤10mL | >10mL | 37 Participants |
| 10 cm | Number of Subjects With a Residual Volume >10mL or ≤10mL | ≤10mL | 23 Participants |
p-value: 1McNemar
Secondary
Number of Subjects With a Residual Volume >30mL or ≤30mL
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7 cm | Number of Subjects With a Residual Volume >30mL or ≤30mL | >30mL | 19 Participants |
| 7 cm | Number of Subjects With a Residual Volume >30mL or ≤30mL | ≤30mL | 41 Participants |
| 10 cm | Number of Subjects With a Residual Volume >30mL or ≤30mL | >30mL | 26 Participants |
| 10 cm | Number of Subjects With a Residual Volume >30mL or ≤30mL | ≤30mL | 34 Participants |
Secondary
Number of Subjects With a Residual Volume >50mL or ≤50mL
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7 cm | Number of Subjects With a Residual Volume >50mL or ≤50mL | >50mL | 15 Participants |
| 7 cm | Number of Subjects With a Residual Volume >50mL or ≤50mL | ≤50mL | 45 Participants |
| 10 cm | Number of Subjects With a Residual Volume >50mL or ≤50mL | >50mL | 16 Participants |
| 10 cm | Number of Subjects With a Residual Volume >50mL or ≤50mL | ≤50mL | 44 Participants |
Secondary
Number of Subjects With a Residual Volume >5mL or ≤5mL
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7 cm | Number of Subjects With a Residual Volume >5mL or ≤5mL | > 5 mL | 42 Participants |
| 7 cm | Number of Subjects With a Residual Volume >5mL or ≤5mL | ≤ 5 mL | 18 Participants |
| 10 cm | Number of Subjects With a Residual Volume >5mL or ≤5mL | > 5 mL | 40 Participants |
| 10 cm | Number of Subjects With a Residual Volume >5mL or ≤5mL | ≤ 5 mL | 20 Participants |
p-value: 0.7905McNemar