A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Overactive Bladder
Corewell Health East
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.
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 BT…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information. 2. Women and men ≥ 18 years of age 3. Self-reported bladder symptoms present ≥ 3 months 4. Self-reported failed conservative care of behavioral modifications and/or oral medications 5. On a stable dose of antimuscarinics/beta-3 agonists for ≥ 4 weeks, and willing to remain on the medication for…
Interventions
- DeviceBTL 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.
- DeviceSham 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.
Location
- Corewell Health William Beaumont University HospitalRoyal Oak, Michigan