Investigation of Novel Non-CE Marked Catheter

MagCath

Status: Enrolling

Conditions: Female Stress Incontinence

Treatments: Device: Obtinu

Study type: Observational

Funder types: Other

Identifiers

NCT06451796

CIV-23-10-044313

Details and patient eligibility

About

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

Full 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?

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.