At a glance
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Assessment of Effectiveness and Safety of a Novel Pessary for the Non-Surgical Treatment of Pelvic Organ Prolapse
In Brief
A clinical study evaluating Reia Vaginal Pessary for Pelvic Organ Prolapse. Completed, enrolled 78 participants across 7 sites.
Detailed Summary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ prolapse (POP) and have already opted for non-surgical management. Recruited patients will have Stage II POP or greater and will be current users of a Gellhorn or ring style pessary. Following enrollment, each subject will enter a 1-month wash out period in which they will continue using their current pessary so that baseline subjective and objective data can be collected. They will then be fit with a study pessary and enter a 3-month treatment phase. Comparative, subjective, and objective data will be collected at the conclusion of the study.
Study Details
Timeline
Interventions
Reia Vaginal Pessary