Female Stress Incontinence
Conditions
Keywords
Female Stress Incontinence
Brief 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?
Interventions
DEVICEObtinu
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
Sponsors
Herlev Hospital
MagCath
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety primary: Migration of device to bladder | 2 weeks | Number of Participants with Migration of device to bladder |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety secondary: Discomfort at catheter removal. | 2 weeks | Number of Participants with discomfort at catheter removal. |
| Safety secondary: Hematuria (stick test/macroscopic). | 2 weeks | Number of Participants with Hematuria (stick test/macroscopic). |
| Safety secondary: Allergy. | 2 weeks | Number of Participants with Allergy. |
| Safety secondary: Loss of device. | 2 weeks | Number of lost devices |
| Safety secondary: Culture confirmed urinary tract infections. | 2 weeks | Number of Participants with urinary tract infections. |
| Safety secondary:Need for antibiotics. | 2 weeks | Number of Participants with need for antibiotics. |
| Safety secondary: Discomfort at self-catheterization. | 2 weeks | Number of Participants with discomfort at self-catheterization. |
| Safety secondary: Difficulties emptying the bladder. | 2 weeks | Number of Participants with difficulties emptying the bladder. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functionality: Is long term continuous use acceptable? | 2 weeks | Is long term continuous use acceptable? |
Countries
Denmark
Contacts
Primary ContactDorthe Snejbjerg, MD Phd
Outcome results
None listed