Comparing Emsella Chair to Sham for Male Sexual Dysfunction
A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction
This study is testing if the Emsella Chair can help men with erectile and ejaculatory dysfunction who haven't found relief with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 117 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Corewell Health East Academic / other |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT05370651 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the Emsella Chair, which utilizes electromagnetic technology, in treating male sexual dysfunction, specifically erectile and ejaculatory dysfunction. It consists of two phases: an open-label pilot study with 10 participants receiving active treatment, followed by a sham-controlled, randomized blinded study involving a total of 114 participants. The goal is to determine if this innovative treatment can improve symptoms of sexual dysfunction in men who have not responded to conventional therapies.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have experienced ejaculatory dysfunction symptoms for more than three months and have not found relief from conservative treatments.
Not a fit: Patients who have received Botox® treatment in the past year or weigh more than 330 pounds may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for men suffering from sexual dysfunction, improving their quality of life.
How similar studies have performed: While there is limited research on the Emsella Chair specifically for sexual dysfunction, similar electromagnetic therapies have shown promise in other areas of treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Royal Oak, Michigan
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth Peters, MD — Corewell Health William Beaumont University Hospital
- Study coordinator: Jo Medado-Ramirez, BSN
- Email: Josephine.Medado-Ramirez@corewellhealth.org
- Phone: 248-551-7360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.