Actively Recruiting
A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction
Led by Corewell Health East · Updated on 2025-12-11
117
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the BTL Emsella Chair, a device using high intensity focused electromagnetic (HIFEM) technology, to treat male sexual dysfunction, specifically ejaculatory dysfunction (EjD) and erectile dysfunction (ED). The study aims to compare the effectiveness of the Emsella Chair against a sham treatment. Ejaculatory dysfunction includes conditions like premature ejaculation, delayed ejaculation, anejaculation, retrograde ejaculation, and painful ejaculation, which are common in aging men and have limited treatment options. The study is conducted in two phases. Phase 1 is an open-label pilot with 10 male participants receiving the active Emsella Chair treatment. If results suggest symptom improvement, Phase 2 will be a randomized, double-blind trial comparing the Emsella Chair to a sham device in up to 117 participants total. Treatments involve sitting on the device while electromagnetic stimulation induces deep pelvic floor muscle contractions. Active treatment involves gradually increasing intensity to the maximum tolerable level, while sham treatment provides some sensation below therapeutic levels. Participants will be evaluated using questionnaires assessing sexual function, including the Global Response Assessment and the Male Sexual Health Questionnaire, at baseline and 4 weeks after completing 8 treatments. Researchers will monitor symptom changes, safety, and tolerability up to 12 to 24 weeks. Participants must be sexually active men aged 18 or older with ejaculatory dysfunction symptoms lasting more than 3 months and previous failed conservative care. The study includes regular assessments and follow-up to measure treatment effects and safety.
CONDITIONS
Brief 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 ejaculatory dysfunction symptoms present for more than 3 months
- Self-reported failure of conservative care such as behavioral changes or oral medications
- Agree not to start new treatments for erectile or ejaculatory dysfunction during study and follow-up periods
You will not qualify if you...
- Botox use in bladder or pelvic floor muscles in the past year
- Weighing more than 330 pounds due to device limits
- Pulmonary insufficiency or related heart and lung symptoms
- Conditions causing loss of normal skin sensation in pelvis, thigh, or buttocks
- Major metal implants including pacemakers, neurostimulators, defibrillators, or metal in pelvic area
- Previous or current penile prosthesis
- Piercing between waist and knees unwilling to be removed before each treatment
- Active urethral diverticula or known urethral stricture disease
- Healing surgical wounds that could be affected by muscle contractions
- Current treatment for malignant tumors interfering with participation
- Previous use of the BTL EMSELLA device
- Sexual dysfunction caused by neurological diseases
- Current use of neuromodulation therapy for bladder symptoms within 3 months
- Participation in other investigational studies or treatments within 30 days
- Any physical condition posing risk or interfering with study results, as determined by investigator
- Note: Some eligibility criteria are withheld to preserve study integrity and will be provided after trial completion
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 treatment sessions over several weeks
Participants receive either active treatment with the Emsella Chair device or a sham treatment. Each session involves sitting on the device while it delivers pelvic floor muscle stimulation or a low-level sham sensation.
8 sessions with the device
Duration - Up to 24 weeks
Participants are followed to assess symptom improvement, safety, and tolerability after completing all treatments.
Visits approximately at 4 weeks and up to 12 to 24 weeks post-treatment
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
J
Jennifer Giordano, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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