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

NCT06846216 | Completed FDA Device

• 1 other identifier: BTL-785_CTUS700
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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

Conditions

Vulvovaginal Atrophy; Urinary Incontinence; Sexual Dysfunction

Keywords

vulvovaginal atrophy; urinary incontinence; sexual dysfunction; radiofrequency; HIFEM; urogenital system

Outcome Measures

Primary Outcomes (1)

• Assessment of Change in Quality of Life of Women with Vulvovaginal Atrophy Symptoms

  The change in the score obtained from the Vulvovaginal Symptoms Questionnaire will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. The score ranges from 0 to 16 for sexually inactive women and from 0 to 20 for sexually active women. An improvement is defined as a decrease in score.

  12 months

Secondary Outcomes (5)

• Assessment of Change in Quality of Life of Women with Urinary Incontinence

  12 months

• Assessment of Change in Sexual Functioning

  12 months

• Assessment of Therapy Comfort

  12 months

• Assessment of Satisfaction

  12 months

• Incidence of Treatment-related Adverse Events

  12 months

Study Arms (1)

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

EXPERIMENTAL

Subjects will undergo six treatment sessions.

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

Interventions

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

Three treatment sessions will consist of the consecutive application of the BTL-785F and HPM-6000UF devices, delivered 5-10 days apart. Three sessions will consist of the standalone application of the HPM-6000UF device, delivered 2-4 days apart. The treatments with BTL-785 device equipped with BTL-785-3 applicator will last 2-10 minutes and with HPM-6000UF 28 minutes.

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

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

Center for Pelvic Health and Wellness

Mission Viejo, California, 92691, United States

Location

Kimberly L. Evans MD, PLLC

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Sexual Dysfunction, Physiological

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 26, 2025
• Study Start: February 20, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

US (2)