Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

Exclusion Criteria

• •1. Women having predominantly urge or mixed incontinence as defined by:
• •1. QUID Urge score \>6, OR
• •2. MESA percentage Urge Score \> MESA percentage Stress Score Note: the questionnaires above will be self-administered and results interpreted by the subjects as per instructions in the questionnaires.
• •2. Current pregnancy, lactation or planning for pregnancy in the next 6 months
• •3. Women at postpartum for 3 months or less prior to screening
• •4. Women currently have an intrauterine device (IUD) as a contraception method placement less than 6 months or have an IUD over 6 month but may replace it next 14 weeks
• •5. Women currently use, have used an intra-vaginal device as contraception method for the past 6 months
• •6. Women currently using a pessary or treated previously with any device for UI
• •7. Women who have been treated with pharmacologic medications for UI within the past 4 months prior to screening, including any antidiuretic or diuretic medications (both over the counter and prescription medications)
• •8. Women who have been previously treated with any surgical or electrical interventions for UI
• •9. Women who have been previously treated with pelvic floor muscle training (PFMT) for UI within the past 4 months prior to screening
• •10. Women who have difficulty inserting or wearing an intra-vaginal device, including a tampon
• •11. Women who participated in a clinical trial within the 12 months prior to screening
• •12. Any of the following known conditions deemed prohibitory:
• •1. Abnormal kidney function, including kidney stone
• •2. Abnormal post void residual (e.g. greater than 150cc) or self-reported difficulty emptying bladder
• •3. Allergy to silicon products and materials
• •4. Acute febrile illness of any cause in the 14 days prior to screening
• •5. Bladder stones or Bladder tumors
• •6. Chronic pelvic pain within the past 4 months prior to screening
• •7. Coagulation abnormalities
• •8. Experience pain or burning sensation during sexual intercourse or urination
• •9. Infections of the vagina, bladder and/or urethra within previous 3 months such as urinary tract infection (UTI)
• •10. Interstitial cystitis
• •11. Neurological disorders such as multiple sclerosis, spina bifida, Parkinson's disease which may interfere with nerve function of the bladder.
• •12. Toxic shock syndrome (TSS) history or symptoms consistent with TSS
• •13. Uncontrolled diabetes
• •14. Undiagnosed vaginal bleeding or hematuria
• •15. Vaginal discharge with a strong odor and irritation within previous 3 months
• •16. Vaginal soreness or pain or fibromyalgia or paravaginal defect
• •13. Any other medical reason that the Investigator determines that the subject should not participate in the study
• •14. Known history of previous pelvic organ prolapse greater than the POP-Q Stage 2 as defined by the international continence society (ICS).