An observational study in Female Stress Incontinence, sponsored by MagCath. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by MagCath · Observational
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:
658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.
This study's planned enrollment of 20 is below the median of 139 across 130 observational studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →This is the only study on the registry with MagCath as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult women suffering from stress urinary incontinence
Exclusion Criteria:
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
Safety 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
Safety secondary: Loss of device.
Number of lost devices
Time frame: 2 weeks
Functionality: Is long term continuous use acceptable?
Is long term continuous use acceptable?
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
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