Randomized, Comparator-controlled, Single Blinded, Multi-center Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

• Participants must be female,

• Must be 18 years of age or older at the time of signing the informed consent

• With BMI \< 35

• Must meet the following 2 criteria for diagnosis of stress urinary incontinence (SUI) :

‣ SUI clinical diagnosis via the cough supine test, AND

⁃ ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) symptoms per the patient

• Women of childbearing potential not intending to become pregnant for the duration of study participation. Subject must agree for the duration of the study to use one of the following forms of contraception

‣ Systemic hormonal treatment including oral pills, patches and injections OR

⁃ Single-barrier contraception (condom, diaphragm and spermicide are each considered a barrier) OR

⁃ Essure® procedure done at least three month prior to screening

• Willing to comply with study requirements, including capable of performing the activities required for the pad weight test and return for follow-up visits.

• Must be able to speak, understand and read English and sign study specific Informed Consent Form