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
100 participants
OBSERVATIONAL
2013-05-31
2025-07-31
Brief Summary
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Detailed Description
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Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stress Urinary Incontinence
Females with stress urinary incontinence, who undergo a tension free surgical sling procedure.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
4. Patient is able to fill in all questionnaires (on judgement of investigator)
Exclusion Criteria
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. The subject has current urinary tract infection.
18 Years
FEMALE
No
Sponsors
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Cantonal Hospital, Frauenfeld
OTHER
Responsible Party
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Prof. Dr. Volker Viereck
Prof. Dr.
Principal Investigators
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Volker Viereck, Physican
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital, Frauenfeld
Locations
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Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TVT 3D
Identifier Type: -
Identifier Source: org_study_id
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