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

Inclusion Criteria:

- be female 18 years or older;

- provide written informed consent prior to study participation and receive a signed
copy;

- be in generally good health as determined by the Investigator;

- have a ≥ 3 month history of experiencing SUI (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:

- 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.