Combination Treatment With BTL-899 and HPM-6000UF Devices II
Muscle Weakness
About this trial
This is an interventional treatment trial for Muscle Weakness
Eligibility Criteria
Inclusion Criteria: Healthy female subjects aged 22 years or older who have given birth to a baby 6 to 60 months prior to their enrolment in the study seeking treatment for strengthening their pelvic floor and abdominal muscles Having a body mass index (BMI) less than 35 kg/m2 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: Ongoing Pregnancy, nursing or IVF procedure 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 Scars in the treatment area Metal containing Intrauterine Device (IUD)
Sites / Locations
- Contour Medical
- Julene B. Samuels
- Southern Urogynecology
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
BTL-899 Treatments
HPM-6000UF 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.