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Combination Treatment With BTL-899 and HPM-6000UF Devices
N/A
Waitlist Available
Research Sponsored by BTL Industries Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights
No Placebo-Only Group
Summary
This trial uses two devices to help elderly patients strengthen their core and pelvic muscles without surgery. The devices make the muscles contract, similar to exercising, which can improve muscle strength and quality of life.
Eligible Conditions
- Pelvic Floor Dysfunction
- Pelvic Floor Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of core muscles strength measured by pressure biofeedback device
Assessment of subject's quality of life based on Subject Satisfaction and Experience Questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BTL-899; HPM-6000UF TreatmentsExperimental Treatment1 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.
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Who is running the clinical trial?
BTL Industries Ltd.Lead Sponsor
54 Previous Clinical Trials
1,862 Total Patients Enrolled