Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

Study Overview
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Brief Summary
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This is a multi-site, randomized, prospective study designed to evaluate the safety and efficacy of the Votiva device headpieces through radiofrequency for vaginal rejuvenation. An anticipated 50 subjects will undergo 3 treatments of the vulvovaginal area using radiofrequency unit or radiofrequency placebo. Study duration for each subject is approximately six months (including screening, 3 treatment sessions 3-4 weeks apart and 2 follow-up visit at 3 and 6 months post initiation of treatment (4 and 12 weeks after completion of last treatment). Efficacy will be measured and evaluated by validated questionnaires to include: The Vulvovaginal Symptoms Questionnaire, Vaginal Laxity Questionnaire (VLQ), Urogenital Distress Short Form (UDI-6) and Incontinence Impact Questionnaire Short Form (IIQ-7), Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R).

Detailed Description
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Vaginal rejuvenation is a catch-all term of aesthetic and functional procedures which claim to provide relief of many issues affecting women's health, ranging from postmenopausal vulvovaginal symptoms (i.e. dryness, burning, itching), stress urinary incontinence, sexual dysfunction or discomfort, vaginal laxity, and external labial appearance, amongst others.1,2 Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions which operate by radiofrequency (RF) delivery, Hybrid Fractional Laser, fractional CO2 laser3, or Er:YAG4. Votiva by InMode is unique in its usage as both an internal and external rejuvenating device. The RF technologies work theoretically by heating the connective tissue of the vaginal wall to 40 to 42°C thereby remodeling extracellular matrix configuration. Once optimal temperatures are reached, collagen contraction, neocollagenesis, vascularization, and growth factor infiltration could lead to durable vaginal wall changes with improvement in elasticity and moisture of the vaginal wall. Although numerous studies have demonstrated the therapeutic efficacy of energy-based devices in rejuvenation of the face, neck, and décolleté, their application in the vaginal canal is a fairly new concept that is currently being studied.11 Given the paucity of data, this study aims to assess the utility and safety of the RF device Votiva in a two arm prospective case control trial for improvement in external labial appearance, vaginal laxity, sexual function and urinary incontinence.

Official Title
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A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

Conditions
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Vaginal Atrophy, Vaginal Relaxation, Stress Urinary Incontinence

Intervention / Treatment
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* Device: Votiva RF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 25-65 years with symptoms of vaginal relaxation syndrome and/or urinary incontinence who desire vaginal rejuvenation treatment. Informed Consent Form, Photo Release and sharing of assessments signed by the subject. Ability and willingness to follow the study visits schedule. Ability and willingness to adhere to prescribed medication regime. Exclusion Criteria: Unable to commit to future appointments within one year Planning on moving away from the New York or Austin area within one year History of other energy-based vaginal therapy within one year Intermittent vaginal hormone replacement therapy. If patients are on hormone replacement therapy, they should maintain their dosing throughout the study. (If using systemic HRT, shouldn't change it during the whole study period) Prior labiaplasty Prior anti-incontinence surgery in the last 12 months Urinary incontinence requiring more than 2 pads/day Urinary tract infection in the past 3 months Immunodeficiency status (steroid intake, ongoing chemotherapy) Diffuse pain syndrome or chronic pain requiring daily narcotics Chronic vaginitis including bacterial vaginosis, HPV, herpes, or other active STI Abnormal Papanicolaou test result in the last 2 years Abnormal pelvic exam (i.e. concerning lesions) or anterior or posterior vaginal prolapse in the last 2 years Undiagnosed abnormal genital bleeding If of child-bearing potential or less than two years postmenopausal, not using a medically approved method of contraception (i.e. oral, transdermal, implanted contraceptives, intrauterine device, diaphragm, condom, etc.) If patients are using a Nuvaring, they must use an alternate form of contraception during the three treatment months Pregnancy (determined by urine HCG prior to procedure) or lactating Psychiatric conditions Pacemaker or internal defibrillator, or other implanted metallic or electronic device. Permanent implant in the treated area such as metal plates and screws or silicone. Current or history of any type of cancer, or pre-malignant conditions. Severe concurrent conditions, such as cardiac disorders. History of or current diseases stimulated by heat, such as recurrent Herpes Simplex, in the area of the vagina where the study device will be applied. This area may be included in the study only following a prophylactic regimen. Poorly controlled endocrine disorders, such as diabetes. Any active skin condition in the treatment area, such as sores, infection, eczema, and rash. History of skin disorders, keloids (irregularly shaped scars), abnormal wound healing, as well as very dry and fragile skin. History of a bleeding disorder in which the blood's ability to form clots is impaired. Any treatment or surgery performed in the treatment area within a year prior to treatment. Use of Isotretinoin (Accutane®) within 6 months prior to treatment. Any therapies or medications which may interfere with the use of the study device. Compromised health as determined by the study doctor.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Votiva RF<br>Patients will undergo radiofrequency treatment using the Votiva FormaV and FractoraV hand pieces, using the device's standard protocol. Patients will have 3 treatments spaced 3-4 weeks apart and two follow-up visits. Duration of each treatment visit is approximately 1-1.5 hours. Prior to treatment and follow-up visit, each patient will be assessed using standardized photos, perineometry, and validated questionnaires. | Device: Votiva RF<br>* The Votiva system is approved by the U.S. Food and Drug Administration for treatment of sexual dysfunction as well as in combination with Kegel exercises for tightening of the muscles of the pelvic floor to increase muscle tone. One part of the system, the fractora handpiece, is approved for tissue coagulation for the purpose of skin rejuvenation. The Votiva has two hand pieces, Forma and Fractora, which have been cleared by the United States Food and Drug Administration (FDA) and are used during dermatological procedures.<br>|
| Sham Comparator: Votiva RF Sham<br>Patients will undergo the acts of receiving radiofrequency treatment with the Votiva FormaV and FractoraV hand pieces, but no direct energy will be applied. Patients will have 3 treatments spaced 3-4 weeks apart and 2 follow-up visits. Duration of each treatment visit is approximately 1-1.5 hours. Prior to treatment and follow-up visit, each patient will be assessed using standardized photos, perineometry, and validated questionnaires. | Device: Votiva RF<br>* The Votiva system is approved by the U.S. Food and Drug Administration for treatment of sexual dysfunction as well as in combination with Kegel exercises for tightening of the muscles of the pelvic floor to increase muscle tone. One part of the system, the fractora handpiece, is approved for tissue coagulation for the purpose of skin rejuvenation. The Votiva has two hand pieces, Forma and Fractora, which have been cleared by the United States Food and Drug Administration (FDA) and are used during dermatological procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual-impact of vulvovaginal symptoms in postmenopausal women | Assessed and measured by: The Vulvovaginal Symptoms Questionnaire (VVSQ) | 6 months | 
| Improved Vaginal Laxity | Vaginal laxity/tightness assessed and measured by: Vaginal Laxity Questionnaire (VLQ) | 6 months | 
| Improved Sexual Function | Sexual dysfunction assessed and measured by: Female Sexual Function Index (FSFI) | 6 months | 
| Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction | Assess distress associated with impaired sexual function assessed and measured by: Female Sexual Distress Scale-Revised Questionnaire | 6 months | 
| Urogenital Distress Inventory | Assessed and measured by: Urogenital Distress Inventory, Short Form (UDI-6) scores | 6 months | 
| Urinary Incontinence Impact | Assessed and measured by: Incontinence Impact Questionnaire Short Form (IIQ-7) | 6 months |