Emsella Chair vs Sham for Male Sexual Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCorewell Health East
About this trial
We will be performing this study in 2 phases: Phase 1 will be an open label pilot study of 10 male participants. All participants in the pilot study will receive active treatment. If data from the pilot study is suggestive of symptom improvement, we will continue on to phase 2, which is a sham controlled, randomized blinded study. Participants in phase 2 will be randomized to receive either active treatment or sham. Potentially a total of 117 participants for both phases will be enrolled.
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 sexual dysfunction, specifically erectile dysfunction (EjD) in men.
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 adverse events and other clinically important information.
Men ≥ 18 years of age.
Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.
Disqualifiers
Botox® use in bladder or pelvic floor muscles in the past year
Subject weighs greater than 330 pounds, due to weight limits of the Emsella Chair.
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, thigh, or buttocks.
Trial design
Treatments tested in this trial
- BTL Emsella Chair
Treatment groups
117 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov