A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction
Corewell Health East
Summary
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.
Description
Male sexual health is an often overlooked and ignored facet of mens well-being. However, this can have significant effects on quality of life for both the man afflicted by sexual dysfunction as well as their partner. Most commonly we think of erectile dysfunction (ED) as the main factor of male sexual dysfunction, but ejaculatory dysfunction (EjD) and other problems relating to orgasm are also important. EjD is exceedingly common especially in the aging male population, and includes premature ejaculation (PE), delayed ejaculation (DE), anejaculation (absence of ejaculation during orgasm), retr…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- 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 adverse events and other clinically important information. 2. Men ≥ 18 years of age. 3. Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks. 5\. Self-reported ejaculatory dysfunction symptoms present \>3 months 6. Self-reported failed conservative care of behavioral modifications and/or oral medi…
Interventions
- DeviceBTL Emsella Chair
Subjects will sit on the device. The clinical research coordinator will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased until the subject reaches 100%.
Location
- Corewell Health William Beaumont University HospitalRoyal Oak, Michigan