Combination of BTL-785F and HPM-6000UF Devices for Women's Intimate Wellness
NCT ID: NCT06846216
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2023-02-20
2024-04-05
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment with BTL-785F and HPM-6000UF Devices
Subjects will undergo six treatment sessions.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
FEMALE
Yes
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Center for Pelvic Health and Wellness
Mission Viejo, California, United States
Kimberly L. Evans MD, PLLC
Sugar Land, Texas, United States
Countries
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Other Identifiers
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BTL-785_CTUS700
Identifier Type: -
Identifier Source: org_study_id
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