Investigation of Novel Non-CE Marked Catheter
A Urethral Valve Catheter for the Treatment of Women With Stress Urinary Incontinence (SUI)
1 other identifier
observational
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedStudy Start
First participant enrolled
June 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJune 21, 2024
June 1, 2024
3 months
May 28, 2024
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety primary: Migration of device to bladder
Number of Participants with Migration of device to bladder
2 weeks
Secondary Outcomes (8)
Safety secondary: Culture confirmed urinary tract infections.
2 weeks
Safety secondary:Need for antibiotics.
2 weeks
Safety secondary: Discomfort at self-catheterization.
2 weeks
Safety secondary: Difficulties emptying the bladder.
2 weeks
Safety secondary: Discomfort at catheter removal.
2 weeks
- +3 more secondary outcomes
Other Outcomes (1)
Functionality: Is long term continuous use acceptable?
2 weeks
Interventions
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
Eligibility Criteria
Adult women suffering from stress urinary incontinence
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MagCathlead
- Herlev Hospitalcollaborator
Study Sites (1)
GynCare
Herlev, DK, 2730, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Pia Sander, MD PhD
Herlev Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 11, 2024
Study Start
June 18, 2024
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share