Testing a new catheter for women with stress incontinence
A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)
This study tests a new catheter designed for women with stress incontinence to see if it’s easy to use and improves their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | MagCath |
| Locations | 1 site (Herlev, DK) |
| Trial ID | NCT06451796 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness and safety of a hydrophilic coated valved intraurethral catheter for treating female stress incontinence. It involves 10 to 20 women who will use the catheter for up to 16 hours a day over a two-week period. The study will assess the ease of insertion, comfort during use, and patient acceptability through symptom and quality of life questionnaires. Additionally, it will analyze dropout rates and motivation to continue using the catheter.
Who should consider this trial
Good fit: Ideal candidates are adult women with daily or almost daily stress urinary incontinence who are motivated to participate and understand Danish.
Not a fit: Patients with allergies to silicone, pregnancy, or certain urinary tract conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for women suffering from stress incontinence.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving treatment options for stress incontinence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Herlev, DK
- GynCare — Herlev, Dk, Denmark (Recruiting)
Study contacts
- Principal investigator: Pia Sander, MD PhD — Herlev Hospital
- Study coordinator: Dorthe Snejbjerg, MD Phd
- Email: info@gyncare.dk
- Phone: (+45) 44 94 12 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.