VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design

The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.

A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is planned. This study is designed to demonstrate that the active treatment (i.e., Viveve Procedure) is superior to the sham treatment for the primary effectiveness and safety endpoints.

Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active treatment group or sham group. The active treatment group will receive a treatment dose of 90 J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.

Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post treatment.

Final data will be reported at 6 months for active and sham treatments.

Key Inclusion Criteria:

1. Able to understand and voluntarily sign the informed consent form
2. Pre-menopausal and ≥ 18 years of age
3. At least one full term vaginal delivery (> 37 completed weeks gestation) at least 12 months prior to enrollment date
4. Experiences vaginal looseness (laxity) during vaginal intercourse
5. Subject must have a screening blood count and metabolic panel including FSH level of <35 mIU/mL (35 IU/L).
6. Subject must have a normal pelvic exam at baseline and negative chlamydia and gonorrhea cultures during the screening period.
7. Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV.
8. Subject must be willing to engage in vaginal intercourse at least once per month.
9. Subject must be in a monogamous, heterosexual relationship for at least six months prior to screening visit with a partner who is sexually functional and available at least 50% of the time.
10. Subject is surgically sterilized, or is willing to use an acceptable method of birth control that was begun at least 3 month prior to screening and to be continued or throughout the duration of the study [i.e., barrier method (e.g., diaphragm), hormonal therapy (subcutaneous, injectable, or oral contraceptive) intrauterine device], or partner is surgically sterilized

Key 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