Disposable Stress Urinary Incontinence Pessary Device Study

The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC)
disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will
evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in
approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by
mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a
quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by
assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal
examination.

Inclusion Criteria:

- • Provision of signed and dated informed consent form

- Literacy must be in English (able to read and understand Informed Consent)

- Stated willingness to comply with all study procedures and availability for the
duration of the study

- Female, aged >18

- Be in generally good heath as determined by the Investigator

- Have a physician diagnosis of SUI that occurred prior to or during the screening
visit of this study

- Have a > 3-month history of experiencing > 3 episodes of SUI per week

- Be willing to use the investigational pessary device for the control of urinary
incontinence

- Have experience with wearing a tampon

- The most recent Pap smear is normal within 36 months.

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