An interventional study of A=SpeediCath Compact 7 cm and B=POBE 10 cm in Catheterization, sponsored by Wellspect HealthCare. Completed at 3 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by Wellspect HealthCare · Not applicable, Interventional, and Other
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.
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.
Wellspect HealthCare is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 7 cm then 10 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 7 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then then 7 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 10 cm then 7 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.
Device: A=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.
Also known as: Coloplast SpeediCath Compact 7 cm, Astra Tech POBE 10 cm
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.
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.
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.
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.
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.
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.
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.
| Milestone | AABB | ABAB | ABBA | BAAB | BABA | BBAA |
|---|---|---|---|---|---|---|
| Started | 10 | 9 | 10 | 10 | 11 | 10 |
| Completed | 10 | 9 | 10 | 10 | 11 | 10 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Residual volume in mL | 7 cm | 10 cm |
|---|---|---|
| Bladder Scan Measurements of Residual Urine Volume | 32.74 ± 41.48 | 34.78 ± 38.76 |
| Participants | 7 cm | 10 cm |
|---|---|---|
| > 5 mL | 42 | 40 |
| ≤ 5 mL | 18 | 20 |
| Participants | 7 cm | 10 cm |
|---|---|---|
| >10mL | 38 | 37 |
| ≤10mL | 22 | 23 |
| Participants | 7 cm | 10 cm |
|---|---|---|
| >30mL | 19 | 26 |
| ≤30mL | 41 | 34 |
| Participants | 7 cm | 10 cm |
|---|---|---|
| >50mL | 15 | 16 |
| ≤50mL | 45 | 44 |
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.
| score on a scale | All Subjects |
|---|---|
| 7 cm | 0.75 ± 0.40 |
| 10 cm | 0.83 ± 0.35 |
| 7 cm - 10 cm | -0.08 ± 0.26 |
Collected over The investigation lasted for 3 months and the adverse events/adverese device effects were collected during this time.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 7 cm | 0/60 (0%) | 0/60 (0%) | 2/60 (3.3%) |
| 10 cm | 0/60 (0%) | 0/60 (0%) | 1/60 (1.7%) |
| Event | 7 cm | 10 cm |
|---|---|---|
| Burning sensation in urethra one hour after catheterizationRenal and urinary disorders | 0/60 | 1/60 |
| Menstrual bleedingReproductive system and breast disorders | 1/60 | 0/60 |
| HeadacheGeneral disorders | 1/60 | 0/60 |
| Age, Continuous(years) | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Mean | 48.20 ± 15.34 |
| Sex: Female, Male(Participants) | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Female | 60 |
| Male | 0 |
| Region of Enrollment(participants) | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Sweden | 60 |
| Weight(Kilogramme) | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Mean | 66.53 ± 13.98 |
| Height(Cm) | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Mean | 163.62 ± 7.48 |
| BMI(kg/m^2) | Four Catheterizations, Each Subject Was Catheterisized Twice With Each Product in a Randomized Order |
|---|---|
| Mean | 24.78 ± 4.52 |
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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