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Disposable Stress Urinary Incontinence Pessary Device Study

Rinovum Women's Health, Inc. · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.
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