Combination Treatment With BTL-899 and HPM-6000UF Devices

Evaluation of the Combination Treatment With BTL-899 and HPM-6000UF Devices for Abdominal and Pelvic Floor Muscle Strengthening and Overall Improvement in Quality of Life in Elderly Patients

This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in elderly patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Floor Disorders
• Intervention / Treatment: Device: BTL-899; HPM-6000UF Treatments

Detailed Description

The study is a prospective, multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete seven (7) treatment visits and two (2) follow-up visits - 1 month and 3 months after the final treatment.

At the baseline visit, medical history will be assessed. Inclusion and exclusion criteria will be verified, and informed consent will be signed. Digital photographs will be taken, waist circumference will be measured, abdominal muscle strength will be measured with a pressure biofeedback device.

The two devices will be used separately in two different treatments. However one treatment visit can comprise both treatments. The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered. The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered. There will be three (3) visits where both treatments will be applied consecutively, starting with BTL-899, followed by the therapy with HPM-6000UF.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Plastic Surgical Associates
  • Georgia
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Men's Health Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female subjects aged 60 years or older (postmenopause when female),
• BMI ≤35kg/m2 seeking treatment for strengthening their pelvic floor or abdominal muscles
• 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.
• Subjects willing and able to abstain from partaking in any concurrent treatments on abdomen and pelvic floor other than the study procedures during study participation.
• Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs taken.

Exclusion Criteria:

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Metal implants in the treated area
• Drug pumps
• Malignant tumor
• Pulmonary insufficiency
• Injured or otherwise impaired muscles in the treated area
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations in the treated area
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Poor healing and unhealed wounds in the treatment area
• Following recent surgical procedures when muscle contraction may disrupt the healing process
• Graves' disease

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: BTL-899; HPM-6000UF Treatments; The two devices will be used separately in two different treatments. However one treatment visit can comprise both treatments. The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered. The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.

Device: BTL-899; HPM-6000UF Treatments; The two devices will be used separately in two different treatments. However one treatment visit can comprise both treatments. The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered. The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of core muscles strength measured by pressure biofeedback device	Change in core muscles strength measured by pressure biofeedback device	5 months
Assessment of subject's quality of life based on Subject Satisfaction and Experience Questionnaire	Change in subject's quality of life based on Subject Satisfaction and Experience	5 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; abdominal muscles; pelvic floor muscles; core strength
• Additional Relevant MeSH Terms: Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: BTL-899_CTUS500

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