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

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