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

NCT05537181 | Unknown FDA Device

• 1 other identifier: BTL-899_CTUS500
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pelvic Floor Disorders

Keywords

core strength; abdominal muscles; pelvic floor muscles; quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BTL-899; HPM-6000UF Treatments

EXPERIMENTAL

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

Interventions

BTL-899; HPM-6000UF Treatments 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.

BTL-899; HPM-6000UF Treatments

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (3)

Plastic Surgical Associates

Fort Collins, Colorado, 80525, United States

Location

Dermatologic Surgery Specialists

Macon, Georgia, 31217, United States

Location

Men's Health Boston

Chestnut Hill, Massachusetts, 02467, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital 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: September 8, 2022
• First Posted: September 13, 2022
• Study Start: February 4, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

US (3)