VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Exclusion Criteria

• •1. Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months.
• •2. Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment
• •3. History of a genital fistula, a thin recto-vaginal septum as determined by the investigator, or history of a fourth degree laceration during screening physical exam
• •4. Clinically significant pelvic organ prolapse
• •5. Currently meets the criteria for a female sexual disorder, including DSM V, FSAD, FOD, Genitopelvic Pain, Sexual Aversion, Dyspareunia, or Vaginismus, and has not been treated for this condition within the past 12 months
• •6. Beck Depression Inventory score \> 14
• •7. DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms
• •8. Taking SSNRI or SSRI drugs
• •9. Not willing to abstain from vaginal intercourse or use of tampons until 10-day follow-up visit completed
• •10. Evidence of active sexually transmitted disease upon vaginal exam that precludes treatment
• •11. History of genital herpes
• •12. Clinically significant abnormalities in clinical chemistry or hematology at the time of screening
• •13. Currently taking prescribed medications, OTC products or supplements that may impact or enhance sexual function (e.g., antihypertensive, psychotropic, chemotherapeutic agent, PD5 Inhibitors) as assessed by the investigator
• •14. Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy
• •15. Has an implantable pacemaker, an automatic implantable cardioverter/defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency fields or current
• •16. Has undergone the Viveve Procedure previously
• •17. Has medical condition that in investigator's opinion may interfere with wound healing response
• •18. Has an acute or a chronic vaginal or vulvar disorder (e.g., vaginal atrophy, pain including vulvodynia, vulvar vestibulitis dysethetic vulvodynia or vulvar dystrophy, current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis lichen planus, tinea cruris, lichen sclerosis, seborrhea dermatitis, contact or irritant dermatitis, lichen simplex, eczema) or bullous dermatoses or systemic diseases with potential involvement of vulva)
• •19. Has Irritable Bowel Syndrome or Crohn's Disease
• •20. Has dyspareunia defined as recurrent or persistent painful intercourse that affects sexual activity
• •21. Has been in another clinical study within four weeks of screening, or is not willing to abstain from enrolling in other clinical studies for duration of trial