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

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

This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).

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