BTL-899 + HPM-6000UF Devices for Pelvic Floor Disorders

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Disqualifiers: Cardiovascular diseases, Malignant tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two devices, BTL-899 and HPM-6000UF, to determine their effectiveness in strengthening core muscles and improving the quality of life in older adults. The BTL-899 targets the abdomen, inducing muscle contractions and mild heating, while the HPM-6000UF focuses on tightening pelvic floor muscles. It suits seniors seeking a non-invasive method to strengthen their core and pelvic muscles without other treatments during the study. Participants must be 60 or older, in good health, and willing to follow all study guidelines. As an unphased trial, this study provides participants the chance to explore innovative, non-invasive treatments for enhancing muscle strength and quality of life.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not undergo any other treatments on your abdomen and pelvic floor during the study.

What prior data suggests that these devices are safe for elderly patients?

Research shows that the BTL-899 device safely and effectively reduces fat without surgery. The FDA has approved it for this purpose, confirming its safety for certain uses. Although specific safety information for muscle use is lacking, its approval suggests some confidence in its safety for other applications.

Studies have shown that the HPM-6000UF device is safe for non-invasive pelvic floor muscle treatment using electromagnetic stimulation. These studies found no major side effects, indicating it is generally well-tolerated.

Both devices have been used safely in various ways. However, their combined use remains under study, so please consider this when deciding to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for muscle toning and strengthening, like traditional exercises or electrical muscle stimulation, require significant time and effort to see results. But the combination of BTL-899 and HPM-6000UF devices offers a unique approach by inducing visible muscle contractions and mild heating with the BTL-899, and targeting pelvic floor muscle contractions with HPM-6000UF. Researchers are excited because these devices promise a more efficient path to muscle conditioning, potentially delivering noticeable improvements with fewer sessions and less physical strain. This innovative method could make muscle strengthening more accessible and convenient for many people.

What evidence suggests that the BTL-899 and HPM-6000UF devices are effective for strengthening core muscles and improving quality of life in elderly patients?

Research shows that the BTL-899 device, which participants in this trial may receive, can improve muscle tone and reduce body fat. Studies have found that it strengthens abdominal muscles and firms the body. The FDA has approved it for these uses, indicating confidence in its effectiveness.

The HPM-6000UF device, another treatment option in this trial, strengthens pelvic floor muscles without surgery, enhancing muscle strength in that area. Researchers study these devices separately in this trial to boost core strength and improve quality of life, especially for older adults. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Hemorrhagic conditions

You have an electronic implant like a pacemaker, defibrillator, or neurostimulator.

You have metal implants in the area being treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive BTL-899 and HPM-6000UF device treatments for muscle strengthening

6 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL-899
• HPM-6000UF

How Is the Trial Designed?

Group I: BTL-899; HPM-6000UF Treatments Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04871503

Study Details | NCT04871503 | High-Intensity Focused ... Study Overview. Brief Summary. This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K192224.pdf

K192224 - David Chmel - accessdata.fda.gov In conclusion, treatment with the BTL-899 device has shown to be both effective and safe for non-invasive lipolysis and circumference reduction ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04587986

rPMS and Radiofrequency for Abdominal Toning ... The device will induce visible muscle contractions along with heating of the subcutaneous fat. Intervention/Treatment, Device : BTL-899. Treatment with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9869942/

A Systematic Review of Electromagnetic Treatments for ... The BTL-899 device received FDA 510(k) clearance for lipolysis and reduction ... Evaluation of safety and efficacy of a new device for muscle toning and body ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240234.pdf

K240234 - David Chmel - accessdata.fda.gov The BTL-899MS device is indicated to be used for: • Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer.

6. withpower.com withpower.com/trial/phase-musculoskeletal-diseases-4-2024-0543f

BTL-899 Device for Musculoskeletal Health Is the BTL-899 device safe for human use? There is no specific safety data available for the BTL-899 device in the provided research articles. How ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04643275?term=AREA%5BBasicSearch%5D(arm)&rank=8

Effect of BTL-899 Device for Non-invasive Lipolysis on ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K230467.pdf

K230467 - David Chmel - accessdata.fda.gov The secondary objectives of the study were to evaluate the safety of the BTL-899 device for non-invasive lipolysis (breakdown of fat) of the ...