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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
Preminger Plastic Surgery
New York, New York, United States
RECRUITINGJennifer L. Walden MD., P.L.L.C.
Austin, Texas, United States
RECRUITINGSexual-impact of vulvovaginal symptoms in postmenopausal women
Assessed and measured by: The Vulvovaginal Symptoms Questionnaire (VVSQ)
Time frame: 6 months
Improved Vaginal Laxity
Vaginal laxity/tightness assessed and measured by: Vaginal Laxity Questionnaire (VLQ)
Time frame: 6 months
Improved Sexual Function
Sexual dysfunction assessed and measured by: Female Sexual Function Index (FSFI)
Time frame: 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
Time frame: 6 months
Urogenital Distress Inventory
Assessed and measured by: Urogenital Distress Inventory, Short Form (UDI-6) scores
Time frame: 6 months
Urinary Incontinence Impact
Assessed and measured by: Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: 6 months
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