Disposable Stress Urinary Incontinence Pessary Device Study

Exclusion Criteria

• •• Is pregnant, or planning to become pregnant during the study
• •* Has been physician diagnosed with urge urinary incontinence or mixed urinary incontinence prior to or during the screening visit for this study
• •* Is post-partum within 3 months
• •* Has had an intrauterine device (IUD) placement of less than 6 months
• •* Has self-reported difficulty emptying her bladder;
• •* Has a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
• •* Has experienced difficulty inserting or wearing an intra-vaginal device, including a tampon;
• •* Has had 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 participant or the outcome of the study
• •* Has an active urinary tract infection or vaginal infection requiring treatment
• •* If for any reason, the Investigator decides that the participant should not participate in the study.
• •* Class III Obesity (BMI\> 40.0 kg/m2)
• •* Advanced prolapse
• •* Fit assessment is not successful during screening visit