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

Primary Purpose

Pelvic Floor Disorders

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

About this trial

This is an interventional treatment trial for Pelvic Floor Disorders focused on measuring core strength, abdominal muscles, pelvic floor muscles, quality of life

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Plastic Surgical Associates
  • Dermatologic Surgery Specialists
  • Men's Health Boston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BTL-899; HPM-6000UF Treatments

Arm Description

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.

Outcomes

Primary Outcome Measures

Assessment of core muscles strength measured by pressure biofeedback device
Change in core muscles strength measured by pressure biofeedback device
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

Secondary Outcome Measures

Full Information

First Posted
September 8, 2022
Last Updated
January 26, 2023
Sponsor
BTL Industries Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05537181
Brief Title
Combination Treatment With BTL-899 and HPM-6000UF Devices
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 Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

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 elderly patients.
Detailed Description
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 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. 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
Pelvic Floor Disorders
Keywords
core strength, abdominal muscles, pelvic floor muscles, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTL-899; HPM-6000UF Treatments
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BTL-899; HPM-6000UF Treatments
Intervention Description
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.
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
Time Frame
5 months
Title
Assessment of subject's quality of life based on Subject Satisfaction and Experience Questionnaire
Description
Change in subject's quality of life based on Subject Satisfaction and Experience
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Plastic Surgical Associates
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Dermatologic Surgery Specialists
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Men's Health Boston
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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