Clinical trial NCT03520426: Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
Official title: A Randomized Controlled Trial for the Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Atrophy
Vaginal Relaxation
Stress Urinary Incontinence
Lead sponsor: Walden, Jennifer L., M.D.,P.L.L.C.
Sponsor class: INDIV
Collaborators: name: Aviva Preminger, MD., P.L.L.C.
name: InMode MD Ltd.
First posted: 2018-05-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: Sexual-impact of vulvovaginal symptoms in postmenopausal women
timeFrame: 6 months
measure: Improved Vaginal Laxity
timeFrame: 6 months
measure: Improved Sexual Function
timeFrame: 6 months
measure: Measuring Sexually Related Personal Distress in Women With Female Sexual Dysfunction
timeFrame: 6 months
measure: Urogenital Distress Inventory
timeFrame: 6 months
measure: Urinary Incontinence Impact
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Preminger Plastic Surgery
state: New York
city: Austin
country: United States
facility: Jennifer L. Walden MD., P.L.L.C.
state: Texas
Study officials:
affiliation: Owner
name: Jennifer L. Walden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Site PI
name: Aviva Preminger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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