A Clinical Study to Assess the Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence

Inclusion Criteria: * be female 18 years or older; * provide written informed consent prior to study participation and been given a signed copy; * be in generally good health as determined by the Investigator; * have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported); * be willing to use the pessary investigational device to control stress urinary incontinence; * be willing to comply with study requirements and instructions; Exclusion Criteria: * are 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 and could impact the safety of the subject or the outcome of the study; or * for any reason, the Investigator decides that the subject should not participate in the study.