BTL-899; HPM-6000UF Treatments for Pelvic Floor Dysfunction

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

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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