RecruitingNCT06451796
Investigation of Novel Non-CE Marked Catheter
A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)
Sponsor
MagCath
Enrollment
20 participants
Start Date
Jun 18, 2024
Study Type
OBSERVATIONAL
Conditions
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
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years
Inclusion Criteria9
- Willing to participate
- Adult, competent woman who understands Danish.
- SUI as dominant symptom; daily or almost daily.
- Residual urine < 150 ml.
- POP-Q prolapse ≤ grade 2.
- Negative urine stix/Urine D+R.
- Min. 2 months local vaginal estrogen treatment if the woman is postmenopausal.
- Mobile and self-reliant woman.
- Motivated.
Exclusion Criteria9
- Allergy to the silicone material
- Pregnancy or breastfeeding
- Unexplained hematuria.
- Current inflammatory disorders
- Malignant disorders of the urethra.
- Urethral stricture
- Visual diverticulum.
- AK treatment.
- Prosthetic heart valve surgery.
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Interventions
DEVICEObtinu
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
Locations(1)
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NCT06451796