Emsella Chair vs Sham for Male Sexual Dysfunction

Launched by WILLIAM BEAUMONT HOSPITALS · May 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special chair called the Emsella Chair, which uses electromagnetic technology, to help men with sexual dysfunction, particularly issues related to ejaculation. The study will happen in two parts. The first part involves 10 men who will all receive the active treatment to see if it helps improve their symptoms. If the results are promising, the second part will include more participants, where some will receive the active treatment and others will receive a sham (fake) treatment, ensuring that neither the participants nor the researchers know who gets which treatment.

To participate, men must be at least 18 years old, have experienced ejaculatory dysfunction symptoms for more than three months, and have been sexually active recently. Participants should also agree not to start any new treatments for their dysfunction during the study. However, there are some exclusions, such as individuals with certain medical conditions or those who have had certain types of treatments recently. If you choose to join the study, you can expect to complete questionnaires about your symptoms and communicate with the study team about your health throughout the process.

Gender

MALE

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.