Actively Recruiting
Investigation of Novel Non-CE Marked Catheter
Led by MagCath · Updated on 2024-06-21
20
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
Sponsors
M
MagCath
Lead Sponsor
H
Herlev Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Investigation of Novel Non-CE Marked Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate
- Adult, competent woman who understands Danish
- Stress urinary incontinence as dominant symptom occurring daily or almost daily
- Residual urine less than 150 ml
- Pelvic organ prolapse quantification (POP-Q) grade 2 or less
- Negative urine dipstick or urine culture
- At least 2 months of local vaginal estrogen treatment if postmenopausal
- Mobile and self-reliant woman
- Motivated to participate
You will not qualify if you...
- Allergy to silicone material
- Pregnancy or breastfeeding
- Unexplained blood in urine
- Current inflammatory disorders
- Malignant disorders of the urethra
- Urethral stricture
- Visible diverticulum
- Treatment with anticoagulants
- History of prosthetic heart valve surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GynCare
Herlev, DK, Denmark, 2730
Actively Recruiting
Research Team
D
Dorthe Snejbjerg, MD Phd
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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