NCT04873037

BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Detailed description

Overactive bladder (OAB) is a common and often debilitating condition in both men and women. OAB symptoms including urinary frequency, urgency, and/or urge incontinence (UI), have been found to negatively impact quality of life. Due to side effects and the lack of patient compliance to pharmacologic treatments for OAB, non-pharmacologic treatments are in high demand for this condition. Neuromodulation therapies have become increasingly popular for the treatment of overactive bladder in men and women. These neuromodulation therapies work in treating OAB by stimulating the pudendal nerve. The BTL EmsellaTM (Emsella Chair) is a conservative neuromodulation therapy that may have a role for patients who are not surgical candidates or who desire a noninvasive treatment option. The ideal treatment for OAB is still lacking. Many patients are interested in pursuing conservative treatment options. The Emsella chair may have a role for patient who do not desire surgery found with SNM or desire a noninvasive treatment option. The Emsella chair is approved as a treatment for stress urinary incontinence (SUI). Overactive bladder patients may benefit from treatment. The Emsella chair generates electromagnetic stimulation which is able to penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation for weak pelvic floor 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.

Conditions

• Overactive Bladder Syndrome
• Overactive Bladder
• Urinary Frequency
• Urinary Urgency

Interventions

Type	Name	Description
DEVICE	BTL Emsella Chair	The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of 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 stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
DEVICE	Sham BTL Emsella Chair	The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (less than 10%) power.

Timeline

• Start date: 2021-11-22
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2021-05-05
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study