Clinical trial NCT05713864: Combination Treatment With BTL-899 and HPM-6000UF Devices II
Official title: 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 Patients After Childbirth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 33
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 female patients after childbirth.

Detailed description: 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 female patients after childbirth. 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 five (5) to (10) days apart 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.

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)

Primary outcomes:
measure: Assessment of core muscles strength measured by pressure biofeedback device
timeFrame: 5 months
measure: Assessment of subject's quality of life based on Subject Satisfaction and Experience
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Contour Medical
state: Arizona
city: River Bluff
country: United States
facility: Julene B. Samuels
state: Kentucky
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
Study officials:
References: