A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
- Conditions
- Catheterization
- Interventions
- Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm
- Registration Number
- NCT00799981
- Lead Sponsor
- Wellspect HealthCare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BABA 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. ABBA 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. BAAB 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. AABB 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 7 cm then 10 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. ABAB 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. BBAA 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 >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. 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 >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. 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.
Trial Locations
- Locations (3)
Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
🇸🇪Gothenburg, Sweden
Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
🇸🇪Borås, Sweden
Clinical Research and Trial Centre, Lund University Hospital
🇸🇪Lund, Sweden