Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness

This study will evaluate the clinical efficacy and performance of the combined application of the BTL-785F and HPM-6000UF devices for the improvement of Quality of Life in Women with in the urogenital system (vulvovaginal atrophy symptoms, urinary incontinence or sexual dysfunction). This clinical trial uses a multicenter, single-arm, open-label, interventional design. Subjects will undergo six treatment sessions.

Follow-up visits are scheduled 1 month, 3 months, and 6 months after the last treatment session.

Participants will complete the Vulvovaginal Symptoms Questionnaire, King's Health Questionnaire, and the 6-item Female Sexual Function Questionnaire, which will be administered at the baseline visit, after the last treatment, and all follow-up visits. Additionally, the Subject Satisfaction Questionnaire, given after the last treatment and at all follow-up visits, will be filled out. Therapy Comfort Questionnaire will be administered after the last treatment. During the study duration, observation for adverse events and side effects will take place.

Inclusion criteria

• Healthy female subjects aged 30 years or older seeking treatment for intimate concerns such as negative changes in the vulvovaginal area, impairment of sexual function, and UI.
• The subject has had at least one full-term pregnancy with vaginal delivery or a C-section.
• Subjects should be able to understand the investigative nature of the treatment, the possible benefits, and side effects, and must sign the Informed Consent Form.
• The subject is willing and able to abstain from partaking in any concurrent treatments of aggravating vulvovaginal changes, other than the study procedures during study participation.
• Willingness to comply with study instructions and to return to the clinic for the required visits.
• Women of childbearing potential are required to use birth control measures.

Exclusion criteria

• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin in the past 12 months
• Skin related autoimmune diseases
• Radiation therapy and chemotherapy
• Poor healing and unhealed wounds in the treatment area
• Metal implants including Intrauterine metal devices
• Nuvaring (Birth Control Vaginal Ring)
• Permanent implant in the treated area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of any type of cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• Pregnancy/nursing or IVF procedure
• History of bleeding coagulopathies, use of anticoagulants
• Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
• Any surgical procedure in the treatment area within the last three months or before - complete healing
• Poorly controlled endocrine disorders, such as diabetes
• Acute neuralgia and neuropathy
• Kidney or liver failure
• Sensitivity disorders in the treatment area
• Varicose veins, pronounced edemas
• Sexually transmitted infection
• Pelvic organ prolapsed beyond the hymenal ring and evidence of fine rectovaginal septum
• Undergoing pelvic floor physiotherapy
• Implanted neurostimulators
• Pulmonary insufficiency
• Drug pumps
• Malignant tumor
• Increased body temperature (above 99°F) and fever (above 100.4 °F)