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

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BTL-899
HPM-6000UF
Sponsored by
BTL Industries Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Arm Label

BTL-899 Treatments

HPM-6000UF Treatments

Arm Description

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.

Outcomes

Primary Outcome Measures

Assessment of core muscles strength measured by pressure biofeedback device
Change in core muscles strength measured by pressure biofeedback device. The maximal pressure before and after the study therapy will be compared for each subject, according to the study phase. Through the change in pressure, the change in strength will be evaluated.
Assessment of subject's quality of life based on Subject Satisfaction and Experience
Change in subject's quality of life based on Subject Satisfaction and Experience Questionnaire. The subjects will answer questions about their lifestyle where the best possible answer is "Strongly agree" and the worst is "Strongly disagree".

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
April 11, 2023
Sponsor
BTL Industries Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05713864
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTL-899 Treatments
Arm Type
Experimental
Arm Description
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.
Arm Title
HPM-6000UF Treatments
Arm Type
Experimental
Arm Description
The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.
Intervention Type
Device
Intervention Name(s)
BTL-899
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HPM-6000UF
Intervention Description
The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.
Primary Outcome Measure Information:
Title
Assessment of core muscles strength measured by pressure biofeedback device
Description
Change in core muscles strength measured by pressure biofeedback device. The maximal pressure before and after the study therapy will be compared for each subject, according to the study phase. Through the change in pressure, the change in strength will be evaluated.
Time Frame
5 months
Title
Assessment of subject's quality of life based on Subject Satisfaction and Experience
Description
Change in subject's quality of life based on Subject Satisfaction and Experience Questionnaire. The subjects will answer questions about their lifestyle where the best possible answer is "Strongly agree" and the worst is "Strongly disagree".
Time Frame
5 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Contour Medical
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Julene B. Samuels
City
River Bluff
State/Province
Kentucky
ZIP/Postal Code
40059
Country
United States
Facility Name
Southern Urogynecology
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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