NCT05370651 Emsella Chair vs Sham for Male Sexual Dysfunction
| NCT ID | NCT05370651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corewell Health East |
| Condition | Male Sexual Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 117 participants |
| Start Date | 2022-12-14 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 117 participants in total. It began in 2022-12-14 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Kenneth Peters, MD
PRINCIPAL INVESTIGATOR
Corewell Health William Beaumont University Hospital
Frequently Asked Questions
Who can join the NCT05370651 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Male Sexual Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05370651 currently recruiting?
Yes, NCT05370651 is actively recruiting participants. Contact the research team at Josephine.Medado-Ramirez@corewellhealth.org for enrollment information.
Where is the NCT05370651 trial being conducted?
This trial is being conducted at Royal Oak, United States.
Who is sponsoring the NCT05370651 clinical trial?
NCT05370651 is sponsored by Corewell Health East. The principal investigator is Kenneth Peters, MD at Corewell Health William Beaumont University Hospital. The trial plans to enroll 117 participants.