BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health East
About this trial
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
Qualifiers
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.
Women and men ≥ 18 years of age
Self-reported bladder symptoms present ≥ 3 months
Self-reported failed conservative care of behavioral modifications and/or oral medications
Disqualifiers
Botox® use in bladder or pelvic floor muscles in the past year
Subject weighs greater than 330 pounds
Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and thighs, at the discretion of the investigator.
Trial design
Treatments tested in this trial
- BTL Emsella Chair
- Sham BTL Emsella Chair
Treatment groups
166 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov