Actively Recruiting
Emsella Chair vs Sham for Male Sexual Dysfunction
Led by Corewell Health East · Updated on 2025-12-11
117
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Emsella Chair vs Sham for Male Sexual Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and provide written informed consent, and comply with study procedures
- Male aged 18 years or older
- Sexually active within the past 12 weeks and planning to be sexually active during the next 12 weeks
- Self-reported symptoms of ejaculatory dysfunction present for more than 3 months
- Self-reported failure of conservative care such as behavioral modifications and/or oral medications
- Agree not to start new treatments for erectile or ejaculatory dysfunction during treatment and follow-up periods
You will not qualify if you...
- Botox use in bladder or pelvic floor muscles within the past year
- Weight greater than 330 pounds due to device limits
- Pulmonary insufficiency with symptoms like difficulty breathing, chest pain, palpitations, swelling, dizziness, or cyanosis
- Conditions causing loss of normal skin sensation in pelvis, thigh, or buttocks
- Major metal implants including plates, screws, joint replacements, pacemakers, drug pumps, neurostimulators, electronic implants, defibrillators, or pelvic metal implants
- Previous or current penile prosthesis
- Piercing between waist and knees not willing to be removed before each treatment
- Active urethral diverticula
- Known urethral stricture disease
- Healing from surgical procedures where muscle contraction may disrupt healing
- Current treatment for malignant tumors interfering with study participation
- Prior use of the BTL Emsella device
- Sexual dysfunction of neurogenic cause such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, or neurogenic bladder
- Use of neuromodulation therapy for bladder symptoms within 3 months prior to screening
- Participation in other investigational studies within 30 days of screening
- Any physical condition that may increase risk or interfere with study results per investigator judgment
- Note: Some criteria have been omitted and will be posted after trial completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
Research Team
J
Jo Medado-Ramirez, BSN
CONTACT
J
Jennifer Giordano, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here