Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

Launched by WALDEN, JENNIFER L., M.D.,P.L.L.C. · Apr 27, 2018

Keywords

ClinConnect Summary

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 I...

Gender

FEMALE

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.