Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Vaginal Atrophy, Vaginal Relaxation, Stress Urinary Incontinence

In brief

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).

Key facts

Study ID

NCT03520426

Run by

Walden, Jennifer L., M.D.,P.L.L.C.

People needed

50

Starts

2018-03-12

Expected to finish

2020-01-30

Last updated by the study team

2018-05-09

Who can join

Age: 25 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Preminger Plastic Surgery — New York, New York, United States (enrolling)
• Jennifer L. Walden MD., P.L.L.C. — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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