Clinical trial NCT06846216: Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness
Official title: Evaluation of the Combined Application of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Urinary Incontinence
Sexual Dysfunction
Keywords: vulvovaginal atrophy
urinary incontinence
sexual dysfunction
radiofrequency
HIFEM
urogenital system
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 25
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of Change in Quality of Life of Women with Vulvovaginal Atrophy Symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of Change in Quality of Life of Women with Urinary Incontinence
timeFrame: 12 months
measure: Assessment of Change in Sexual Functioning
timeFrame: 12 months
measure: Assessment of Therapy Comfort
timeFrame: 12 months
measure: Assessment of Satisfaction
timeFrame: 12 months
measure: Incidence of Treatment-related Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Center for Pelvic Health and Wellness
state: California
city: Sugar Land
country: United States
facility: Kimberly L. Evans MD, PLLC
state: Texas
Study officials:
References: