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

Status unconfirmed · Not applicable

Conditions studied: Pelvic Floor Disorders

In brief

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.

Key facts

Study ID

NCT05537181

Run by

BTL Industries Ltd.

People needed

39

Starts

2022-02-04

Expected to finish

2023-06-01

Last updated by the study team

2023-01-27

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

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
• Following recent surgical procedures when muscle contraction may disrupt the healing process
• Graves' disease

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.