Emsella Chair Vs Sham for Male Sexual Dysfunction

Last updated: September 12, 2024
Sponsor: William Beaumont Hospitals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Men's Health

Erectile Dysfunction

Sexual Dysfunction

Treatment

BTL Emsella Chair

Clinical Study ID

NCT05370651
2022-165
  • Ages > 18
  • Male

Study 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 total of 114 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

Inclusion Criteria:

  1. Able to read, understand, and provide written, dated, informed consent prior toscreening, and be likely to comply with study protocol, including independentlycomplete study questionnaires and communicate with study personnel about adverseevents 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 thenext 12 weeks.

  4. Self-reported ejaculatory dysfunction symptoms present >3 months 6. Self-reportedfailed conservative care of behavioral modifications and/or oral medications.

  5. Subject agrees not to start any new treatment for erectile dysfunction orejaculatory dysfunction during the treatment and follow-up periods.

Exclusion

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, especiallyduring exercise; chest pain, such as squeezing, pressure of tightness; the sensationof 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, orbuttocks.

  5. Major metal implants such as: metal plates, screws, joint replacements, implantedcardiac pacemakers, drug pumps, neurostimulators, electronic implants,defibrillators, and metal implants in the pelvic area. Patients with other metalimplants 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 itbefore each treatment

  8. Active urethral diverticula

  9. Known history of urethral stricture disease

  10. Currently healing from surgical procedures where muscle contraction may disrupt thehealing process

  11. Subject is currently receiving treatment for a malignant tumor that would interferewith 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, neurogenicbladder etc.

  14. Current use of neuromodulation therapy, including Interstim and percutaneous tibialnerve 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 orpreviously received an investigational drug or treatment within 30 days of theScreening 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 theeligibility criteria have been left off the list posted while the trial isongoing. A full list of eligibility criteria will be posted upon completion ofthe trial.

Study Design

Total Participants: 114
Treatment Group(s): 1
Primary Treatment: BTL Emsella Chair
Phase:
Study Start date:
December 14, 2022
Estimated Completion Date:
January 31, 2027

Study Description

Male sexual health is an often overlooked and ignored facet of mens well-being. However, this can have significant effects on quality of life for both the man afflicted by sexual dysfunction as well as their partner. Most commonly we think of erectile dysfunction (ED) as the main factor of male sexual dysfunction, but ejaculatory dysfunction (EjD) and other problems relating to orgasm are also important. EjD is exceedingly common especially in the aging male population, and includes premature ejaculation (PE), delayed ejaculation (DE), anejaculation (absence of ejaculation during orgasm), retrograde ejaculation, and painful ejaculation. Medications such as sildenafil (Viagra) and tadalafil (Cialis) are Phosphodiesterase type 5 (PDE-5) inhibitors that are commonly used for the treatment of ED, but there are very few medications specifically formulated to treat EjD. More conservative management options for the treatment of ED include vacuum erection devices, psychotherapy, and lifestyle changes. The usual next step after failure of the above options includes intracavernosal injections which involve directly injecting erectogenic medication into the penis, intraurethral injections, or finally surgery. Ejaculatory dysfunction on the other hand, whether it be premature, delayed, retrograde, or anejaculation all have much less treatment options. Most of these include either the off-label use of medications to treat other conditions or sex therapy / psychotherapy.

Treatments including pudendal neuromodulation or pudendal canal decompression have shown significant improvement in ED and EjD. Due to side effects and the lack of patient compliance to oral medication, non-oral medication treatments are in high demand for this condition. Neuromodulation therapies have become increasingly popular for the treatment of male sexual dysfunction. These neuromodulation therapies often work by stimulating the sacral nerve. The Emsella Chair is a conservative neuromodulation therapy that may have a role for patients who are not surgical candidates or who desire a noninvasive treatment option. The Emsella Chair uses high intensity focused electromagnetic (HIFEM) technology to induce deep pelvic floor muscle contractions, the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment awakens deconditioned pelvic floor muscles, delivers the stimulations, and then relaxes the muscles. The repetition of these phases leads to pelvic floor adaptation and remodulation. this treatment could provide similar improvement for men with sexual dysfunction given the significant overlap in anatomy and physiology, as well as studies that have shown improvement in sexual dysfunction with pelvic floor muscle therapy.

Connect with a study center

  • Beaumont Hospital Royal Oak

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Beaumont Hospital-Royal Oak

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.