Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-06-18
2024-09-30
Brief Summary
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Test persons: Ten to twenty stress incontinent women. Treatment time: Up to two weeks
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Detailed Description
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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?
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Obtinu
Treatment of Female Stress Incontinence with a hydrophilic coated valved intraurethral catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy or breastfeeding
* Unexplained hematuria.
* Current inflammatory disorders
* Malignant disorders of the urethra.
* Urethral stricture
* Visual diverticulum.
* AK treatment.
* Prosthetic heart valve surgery.
18 Years
75 Years
FEMALE
No
Sponsors
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Herlev Hospital
OTHER
MagCath
UNKNOWN
Responsible Party
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Principal Investigators
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Pia Sander, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital
Locations
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GynCare
Herlev, DK, Denmark
Countries
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Central Contacts
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Facility Contacts
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Tanja Vang
Role: primary
Other Identifiers
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CIV-23-10-044313
Identifier Type: -
Identifier Source: org_study_id
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