BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stress Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be randomized 1:1 to receive active Emsella chair treatments or sham treatments. Study will be performed in a single-blind manner.(Participant and biostatistician)Masking: Double (Participant, Outcomes Assessor)Masking Description: Randomization will be performed using a table of random numbers. A unblinded RNC will be responsible for maintaining the enrollment and randomization log. Randomization envelopes will be provided by the study's biostatistician and will be securely stored in a locked cabinet. The study coordinator(s) will solely be responsible for opening the randomization envelopes and delivering the study treatments, according to group assignment. Ultimately, they will be responsible for maintaining the confidentiality and security of the randomization envelopes. After randomization, the study coordinator(s) will complete the Subject Enrollment and Randomization Log. The log may be stored in a locked cabinet with the randomization envelopes. At study completion the log will be stored in the regulatory binder.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This is a prospective, sham-controlled, observational study of subjects undergoing electromagnetic perineal stimulation for the treatment of SUI. Eligible subjects will be randomized to receive active treatment or sham in a 1:1 ratio. Eight treatments (2 treatments each week) for 4 weeks will be com...
This is a prospective, sham-controlled, observational study of subjects undergoing electromagnetic perineal stimulation for the treatment of SUI. Eligible subjects will be randomized to receive active treatment or sham in a 1:1 ratio. Eight treatments (2 treatments each week) for 4 weeks will be completed with the Emsella chair to the pelvic floor muscles. Electromagnetic stimulation of the pelvic floor is a FDA approved therapy whereby a coil generates pulsed electromagnetic fields that penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation of weak pelvic muscles.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.This technology is typically not covered by insurance, is minimally invasive, and safe, but has limited data available. Currently, there is no data available from sham controlled studies evaluating efficacy of this technology. The purpose of this study is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of SUI.
Tracking Information
- NCT #
- NCT04133675
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kenneth Peters, MD Beaumont Hospital-Royal Oak
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