A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

Inclusion Criteria:

- have a ≥ 3 month history of experiencing Stress Urinary Incontinence

- be willing to use the pessary investigational device to control stress incontinence

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

- 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

- for any reason, the Investigator decides that the subject should not participate in
the study