Emsella Chair Therapy for Erectile Dysfunction

(Emsella_EJD Trial)

Recruiting at 1 trial location

Overseen By Kenneth Peters, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: William Beaumont Hospitals

Must not be taking: Neuromodulation therapy

Disqualifiers: Pulmonary insufficiency, Major metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

114 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on men with ejaculatory dysfunction who have limited treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not start any new treatments for erectile or ejaculatory dysfunction during the study.

How does Emsella Chair Therapy differ from other treatments for erectile dysfunction?

Emsella Chair Therapy is unique because it uses electromagnetic energy to stimulate pelvic floor muscles, which is a non-invasive approach compared to other treatments like oral medications or injections. This therapy is typically used for strengthening pelvic muscles and improving blood flow, which can help with erectile dysfunction. ^{1 2 3 4 5}

Research Team

Kenneth M Peters, MD

Principal Investigator

Beaumont Hospital Royal Oak

Eligibility Criteria

Men aged 18 or older with erectile or ejaculatory dysfunction for more than 3 months, who have tried and failed conservative treatments. They must not start new treatments during the study, be sexually active, able to consent and follow the protocol. Exclusions include those over 330 pounds, with major metal implants in the pelvic area, recent Botox® in bladder/pelvic muscles, piercings they can't remove from waist to knees, certain medical conditions like neurogenic sexual dysfunction or pulmonary insufficiency.

Inclusion Criteria

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.

I agree not to start new treatments for sexual dysfunction during the study.

I am a man aged 18 or older.

Exclusion Criteria

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.

Subject has used the BTL EMSELLA device previously.

Previous or current penile prosthesis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Open-label Pilot Study

10 male participants receive active treatment with the Emsella Chair to assess initial symptom improvement

8 weeks

Phase 2: Sham Controlled Randomized Study

Participants are randomized to receive either active treatment or sham treatment with the Emsella Chair

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension (optional)

Participants in the sham group may opt into receiving active treatment and will be monitored for adverse events

Up to 12 weeks

Treatment Details

Interventions

• BTL Emsella Chair

Trial Overview The trial is testing if electromagnetic technology via the Emsella Chair can treat sexual dysfunction in men. Phase 1 is an open-label pilot with all receiving treatment; phase 2 will randomly assign participants to receive either active treatment or a sham (fake) intervention to compare effectiveness.

Participant Groups

Group I: Emsella Chair Active Treatment Active Control 1 Intervention

Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will be decreased slightly and stay unchanged for the remainder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.

Group II: Emsella Chair Sham Treatment Placebo Group 1 Intervention

Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (\<10% power).

BTL Emsella Chair is already approved in United States for the following indications:

Approved in United States as BTL Emsella Chair for:

• Urinary incontinence in women and men
• Sexual dysfunction including erectile dysfunction

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Findings from Research

The Osbon ErecAid Vacuum Therapy System significantly improved erectile function in 70 patients aged 25-66 who did not respond to PDE-5 inhibitors, with IIEF-5 scores increasing from 10.2 to 13.3 after 3 months of treatment.

The therapy demonstrated a 77.1% effectiveness rate, with over 64% of both patients and their partners reporting increased sexual satisfaction, indicating its potential as a viable treatment option for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vacuum therapy for erectile dysfunction that fails to respond to PDE-5i: report of 70 cases]. Li, P., Shen, YJ., Liu, TQ., et al.[2013]

Low-intensity extracorporeal shockwave therapy (LI-ESWT) is effectively used to treat erectile dysfunction (ED) in various conditions, including after nerve-sparing prostate surgery and Peyronie's disease.

This case study highlights the successful application of LI-ESWT in a 39-year-old man who developed ED following penile trauma, suggesting its potential as a treatment option for ED resulting from injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction after penile trauma. Stoykov, B., Kolev, N., Dunev, V., et al.[2020]

Erectile dysfunction (ED) is often managed by non-urologists through counseling and lifestyle advice, but many patients may benefit from more effective treatments like intracavernous self-injection or penile prosthesis implantation, which are currently limited to specialized healthcare centers.

There is a debate in the Netherlands about allowing over-the-counter sales of erection pills, as many are sold illegally, highlighting the need for better access to safe and effective treatments for ED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Erectile dysfunction from a urological perspective]. van Driel, MF., Meuleman, EJH.[2018]

Low-intensity shockwave therapy (Li-ESWT) significantly improved erectile function in 70.7% of patients who did not respond to oral medications, with a mean increase of 8.6 points on the International Index of Erectile Function after treatment.

Li-ESWT was safe and effective, enhancing both erectile function and quality of life, as evidenced by significant improvements in penile blood flow measurements and patient-reported outcomes after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial. Palmieri, A., Arcaniolo, D., Palumbo, F., et al.[2021]

Sildenafil is highlighted as the first-line treatment for erectile dysfunction (ED) due to its efficacy, safety, and convenience as the only orally administered erectogenic drug available.

The article outlines a treatment hierarchy for ED, with first-line therapies including sildenafil, vacuum constriction devices, and psychological counseling, while second and third-line options involve more invasive procedures like injections and penile implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current paradigms in treating erectile dysfunction. Padma-Nathan, H.[2015]

References

1. China pubmed.ncbi.nlm.nih.gov

[Vacuum therapy for erectile dysfunction that fails to respond to PDE-5i: report of 70 cases]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction after penile trauma. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Erectile dysfunction from a urological perspective]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Current paradigms in treating erectile dysfunction. [2015]