VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

Conditions
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Vaginal Laxity Following Childbirth, Sexual Function Following Childbirth

Intervention / Treatment
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* Device: Active Treatment Viveve
* Device: Sham Treatment Viveve


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and voluntarily sign the informed consent form Pre-menopausal and ≥ 18 years of age At least one full term vaginal delivery (> 37 completed weeks gestation) at least 12 months prior to enrollment date Experiences vaginal looseness (laxity) during vaginal intercourse Subject must have a screening blood count and metabolic panel including FSH level of <35 mIU/mL (35 IU/L). Subject must have a normal pelvic exam at baseline and negative chlamydia and gonorrhea cultures during the screening period. Subject had a normal PAP within last three years, cytology, no HPV and within last five years, cytology and no HPV. Subject must be willing to engage in vaginal intercourse at least once per month. 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. 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: Pregnant or planning to become pregnant within the next 12 months or has had a delivery within the last 12 months. Currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment 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 Clinically significant pelvic organ prolapse 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 Beck Depression Inventory score > 14 DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms Taking SSNRI or SSRI drugs Not willing to abstain from vaginal intercourse or use of tampons until 10-day follow-up visit completed Evidence of active sexually transmitted disease upon vaginal exam that precludes treatment History of genital herpes Clinically significant abnormalities in clinical chemistry or hematology at the time of screening 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 Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy 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 Has undergone the Viveve Procedure previously Has medical condition that in investigator's opinion may interfere with wound healing response 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) Has Irritable Bowel Syndrome or Crohn's Disease Has dyspareunia defined as recurrent or persistent painful intercourse that affects sexual activity 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Viveve Treatment<br>Intervention in the active arm will be with the Viveve System using 90 Joules/cm2 active treatment with radiofrequency energy in the vaginal introitus | Device: Active Treatment Viveve<br>* Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus<br>|
| Placebo Comparator: Sham Viveve Treatment<br>Intervention in the sham arm will be with the Viveve System using ≤1 Joule/cm2 sham treatment with radiofrequency energy in the vaginal introitus | Device: Sham Treatment Viveve<br>* Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score | The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit. | 6 months | 
| Reporting Adverse Events (AEs) | Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score | Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity (looseness) and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning. | 6 months | 
| Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ) | Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = Very Loose and 7 = Very Tight. The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit. | 6 months | 
| Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R) | The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a worse outcome. The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal laxity, Sexual Function