Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AABB | Experimental | 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. |
|
| ABAB | Experimental | 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. |
|
| ABBA | Experimental | 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. |
|
| BAAB | Experimental | 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. |
|
| BABA | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A=SpeediCath Compact 7 cm and B=POBE 10 cm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulf Malmqvist, MD, PhD, Assoc.Prof. | Clinical Research and Trial Centre, Lund University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabiliteringskliniken, Södra Älvsborgs Sjukhus | Borås | SE-501 82 | Sweden | |||
| Verksamhet Urologi, Sahlgrenska Universitetssjukhuset |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects in the investigation | Posted | Mean | Standard Deviation | Residual volume in mL | 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. |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 7 cm | Coloplast SpeediCath Compact catheter, 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning sensation in urethra one hour after catheterization | Renal and urinary disorders | Systematic Assessment | One subject in the investigational group (10 cm catheter) reported burning sensation in urethra one hour after catheterization possibly due to the catheter. The burning sensation disappeared without any action taken. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Affairs | Wellspect Health Care | +46313763000 | mace@wellspect.com |
Not provided
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.
Not provided
Not provided
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.
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. |
|
| BBAA | Experimental | 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. |
|
|
|
| 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) | 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. | Question asked minutes after catheterization. |
| Gothenburg |
| SE-413 45 |
| Sweden |
| Clinical Research and Trial Centre, Lund University Hospital | Lund | SE-221 85 | Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kilogramme |
|
| Height | Mean | Standard Deviation | Cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| 10 cm |
All study participants were catheterizised with both catheters twice in a randomized order. Every subject is its' own control. |
|
|
|
| Secondary | Number of Subjects With a Residual Volume >5mL or ≤5mL | All subjects participating in the investigation. | Posted | Count of Participants | Participants | 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. |
|
|
|
|
| Secondary | Number of Subjects With a Residual Volume >10mL or ≤10mL | All subjecs participating in the investigation. | Posted | Count of Participants | Participants | 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. |
|
|
|
|
| Secondary | Number of Subjects With a Residual Volume >30mL or ≤30mL | All subjects in the investigation. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Secondary | Number of Subjects With a Residual Volume >50mL or ≤50mL | All subjects participating in the investigation. | Posted | Count of Participants | Participants | 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. |
|
|
|
| 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. | All subjects participating in the investigation. | Posted | Mean | Standard Deviation | score on a scale | Question asked minutes after catheterization. |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | 10 cm | Astra Tech POBE catheter, 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. | 0 | 60 | 0 | 60 | 1 | 60 |
|
| Menstrual bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|