A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)

Exclusion Criteria

• •pregnant, lactating or planning to become pregnant during the study;
• •within 3 months post partum;
• •intrauterine device (IUD) placement of less than 6 months;
• •has self-reported difficulty emptying her bladder;
• •a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
• •experience difficulty inserting or wearing an intra-vaginal device, including a tampon;
• •vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
• •has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the subject or the outcome of the study;
• •for any reason, the Investigator decides that the subject should not participate in the study.