A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaginal Atrophy
- Sponsor
- Walden, Jennifer L., M.D.,P.L.L.C.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Jennifer Walden
Jennifer L. Walden, MD, FACS
Walden, Jennifer L., M.D.,P.L.L.C.
Eligibility Criteria
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
Outcomes
Primary Outcomes
Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction
Time Frame: 6 months
Assess distress associated with impaired sexual function assessed and measured by: Female Sexual Distress Scale-Revised Questionnaire
Urogenital Distress Inventory
Time Frame: 6 months
Assessed and measured by: Urogenital Distress Inventory, Short Form (UDI-6) scores
Improved Vaginal Laxity
Time Frame: 6 months
Vaginal laxity/tightness assessed and measured by: Vaginal Laxity Questionnaire (VLQ)
Improved Sexual Function
Time Frame: 6 months
Sexual dysfunction assessed and measured by: Female Sexual Function Index (FSFI)
Urinary Incontinence Impact
Time Frame: 6 months
Assessed and measured by: Incontinence Impact Questionnaire Short Form (IIQ-7)
Sexual-impact of vulvovaginal symptoms in postmenopausal women
Time Frame: 6 months
Assessed and measured by: The Vulvovaginal Symptoms Questionnaire (VVSQ)