RecruitingNot ApplicableNCT04133675

BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Sponsor

Corewell Health East

Enrollment

110 participants

Start Date

Dec 18, 2019

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence

Summary

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BTL Emsella and a medical device called Sham BTL Emsella for people with stress urinary incontinence. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBTL Emsella

The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimlulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.

DEVICESham BTL Emsella

Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (\<10% power).