BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
Trial Parameters
Brief 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.
Eligibility Criteria
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 the duration of the study OR discontinued antimuscarinics/beta-3 agonists for ≥ 2 weeks 6. Ambulatory and able to use a toilet independently, without difficulty 7. Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods. For Females Only: 8. If of child-bearing age and female, agree to practice approved birth-control methods (oral