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

Evaluation of the Combined Application of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Sexual Dysfunction; Vulvovaginal Atrophy
• Intervention / Treatment: Device: Treatment with BTL-785F and HPM-6000UF Devices

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 92691
      • Center for Pelvic Health and Wellness
  • Texas
    • Sugar Land, Texas, United States, 77478
      • Kimberly L. Evans MD, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment with BTL-785F and HPM-6000UF Devices; Subjects will undergo six treatment sessions.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Change in Quality of Life of Women with Urinary Incontinence	The change in the score obtained from the King's Health 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 between 0 to 100 for the nine domains, and between 0 to 30 for the Symptom Severity Scale. An improvement is defined as a decrease in score.	12 months
Assessment of Change in Sexual Functioning	The change in the score obtained from the 6-item Female Sexual Function Index 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 between 0 to 30. An improvement is defined as an increase in score.	12 months
Assessment of Therapy Comfort	Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Pain Rating Scale (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Pain Rating Scale indicate higher therapy comfort.	12 months
Assessment of Satisfaction	Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Subject Satisfaction questionnaire. The questionnaire will be administered after the last treatment, and at the 1-month, 3-month, and 6-month follow-up visits. Responses to questions about the treated urogenital area will range from "strongly agree" (1 point) to "strongly disagree" (5 points). A higher score for each statement indicate better outcomes.	12 months
Incidence of Treatment-related Adverse Events	Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the combined application of the BTL-785F and HPM-6000UF devices and to identify side effects and adverse events associated with the study treatment.	12 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: sexual dysfunction; urinary incontinence; vulvovaginal atrophy; radiofrequency; HIFEM; urogenital system
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Atrophy
• Other Study ID Numbers: BTL-785_CTUS700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No