NCT00799981

A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization

A Multi Centre, Single-blind, Randomized, Cross-over Study Comparing Two Female Catheters With Different Length in Terms of Residual Urine After Intermittent Catheterization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Catheterization

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2008-12-01
• Last updated: 2021-05-18
• Results posted: 2021-05-18

Locations

3 sites across 1 country: Sweden