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

BTL

Status: Completed

Conditions: Sexual Dysfunction; Vulvovaginal Atrophy; Urinary Incontinence

Treatments: Device: Treatment with BTL-785F and HPM-6000UF Devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846216

BTL-785_CTUS700

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the combined application of BTL-785F and HPM-6000UF Devices in improving quality of life in women with negative changes in the urogenital system (vulvovaginal atrophy symptoms, urinary incontinence or sexual dysfunction). The main question it aims to answer is:

Does the combined application of BTL-785F and HPM-6000UF Devices reduces the score of the Vulvovaginal Symptoms Questionnaire?

Participants will:

• Undergo 6 treatment sessions.Three sessions will consist of combined application of BTL-785F and HPM-6000UF devices and three sessions will consist of standalone application of the HPM-6000UF device.
• Attend follow-up visits
• Complete questionnaires

Full description

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.

Enrollment: 25 patients

Sex: Female

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment with BTL-785F and HPM-6000UF Devices

Experimental group

Description:

Subjects will undergo six treatment sessions.

Treatment:

Device: Treatment with BTL-785F and HPM-6000UF Devices