Could a chair improve Men's sexual function? new trial investigates
NCT ID NCT05370651
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This study tests whether the BTL Emsella Chair, a device that uses electromagnetic energy, can help men with sexual dysfunction, including erectile and ejaculatory problems. The trial has two phases: first, a small pilot study where all 10 men get active treatment, followed by a larger phase where 117 men are randomly assigned to either the real chair or a sham (fake) treatment. Participants report changes in symptoms using questionnaires. The goal is to see if the chair offers a non-invasive treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BTL Emsella Chair (electromagnetic device)
- What this could lead to
- If it works, this could offer a non-invasive, drug-free option to help men with sexual dysfunction improve symptoms.
- What could go wrong
- This is an early study with a small pilot phase and a sham control. The device may not work better than placebo, and results may not apply to all men.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 117 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 medications. 7\. Subject agrees not to start any new treatment for erectile dysfunction or ejaculatory dysfunction during the treatment and follow-up periods. Exclusion Criteria: 1. Botox® use in bladder or pelvic floor muscles in the past year 2. Subject weighs greater than 330 pounds, due to weight limits of the Emsella Chair. 3. 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) 4. Any condition that causes a lack of normal skin sensation to the pelvis, thigh, or buttocks. 5. Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study. 6. Previous or current penile prosthesis. 7. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment 8. Active urethral diverticula 9. Known history of urethral stricture disease 10. Currently healing from surgical procedures where muscle contraction may disrupt the healing process 11. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation. 12. Subject has used the BTL EMSELLA device previously 13. Subject has sexual dysfunction of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc. 14. Current use of neuromodulation therapy, including Interstim and percutaneous tibial nerve stimulation (PTNS), for bladder symptoms within 3 months of screening visit (if past sacral/pudendal implant, must be explanted) 15. Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit 16. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation * Note for the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Corewell Health William Beaumont University Hospital
RECRUITINGRoyal Oak, Michigan, 48073, United States
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