NCT06451796

Investigation of Novel Non-CE Marked Catheter

A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: MagCath · Unknown
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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?

Conditions

• Female Stress Incontinence

Interventions

Type	Name	Description
DEVICE	Obtinu	Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter

Timeline

• Start date: 2024-06-18
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2024-06-11
• Last updated: 2024-06-21

Locations

1 site across 1 country: Denmark