Hypothesis: Treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective, well tolerated and seemingly safe for treatment of women with stress incontinence. Test persons: Ten to twenty stress incontinent women. Treatment time: Up to two weeks
Demonstrate ease and comfort of device insertion, indwelling and removal. Patient acceptability during use. Other: * Symptom and QOL questionnaire. * Drop out analysis. * Is the patient motivated to continue using the valve catheter? * Is the patient motivated to recommend the valve catheter to other stress incontinent women?
Study Type
OBSERVATIONAL
Enrollment
20
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
GynCare
Herlev, DK, Denmark
RECRUITINGSafety primary: Migration of device to bladder
Number of Participants with Migration of device to bladder
Time frame: 2 weeks
Safety secondary: Culture confirmed urinary tract infections.
Number of Participants with urinary tract infections.
Time frame: 2 weeks
Safety secondary:Need for antibiotics.
Number of Participants with need for antibiotics.
Time frame: 2 weeks
Safety secondary: Discomfort at self-catheterization.
Number of Participants with discomfort at self-catheterization.
Time frame: 2 weeks
Safety secondary: Difficulties emptying the bladder.
Number of Participants with difficulties emptying the bladder.
Time frame: 2 weeks
Safety secondary: Discomfort at catheter removal.
Number of Participants with discomfort at catheter removal.
Time frame: 2 weeks
Safety secondary: Hematuria (stick test/macroscopic).
Number of Participants with Hematuria (stick test/macroscopic).
Time frame: 2 weeks
Safety secondary: Allergy.
Number of Participants with Allergy.
Time frame: 2 weeks
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Safety secondary: Loss of device.
Number of lost devices
Time frame: 2 weeks