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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TERMINATED
NA
21 participants
INTERVENTIONAL
2019-12-18
2023-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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3D translabial ultrasound
3D translabial ultrasound with concurrent vaginal manometry
3D translabial ultrasound
All patients will undergo 3D translabial ultrasound with vaginal manometry
Interventions
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3D translabial ultrasound
All patients will undergo 3D translabial ultrasound with vaginal manometry
Eligibility Criteria
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Inclusion Criteria
* are able to provide informed consent
* can perform self-care, i.e. removing and inserting the pessary themselves
* are willing to remove their pessary two days before the ultrasound examination date
Exclusion Criteria
* inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
* history of pelvic radiation or surgery (excluding hysterectomy)
* using pessaries other than ring, incontinence dish, donut, Shaatz
* inability to perform the Valsalva maneuver or pelvic floor contraction
* restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit
* lack of sensation at the pelvic floor
* being pregnant at the time of the examination
FEMALE
No
Sponsors
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Cosm Medical Corporation
UNKNOWN
Western University, Canada
OTHER
Responsible Party
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Locations
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Western University
London, Ontario, Canada
Countries
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Other Identifiers
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6086
Identifier Type: OTHER
Identifier Source: secondary_id
113264
Identifier Type: -
Identifier Source: org_study_id
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