Emsella Chair Therapy for Erectile Dysfunction

(Emsella_EJD Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Giordano, BSN

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

117 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Emsella Chair, which uses electromagnetic technology, can treat erectile dysfunction in men. In the first phase, all participants receive the treatment to assess its potential. If initial results are positive, the second phase will compare the real treatment to a placebo to determine its true effectiveness. Men with ejaculatory dysfunction symptoms for over three months who have not found success with other treatments might be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to explore a novel treatment option that could potentially improve their condition.

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.

What prior data suggests that the Emsella Chair is safe for treating erectile dysfunction?

Research has shown that the Emsella Chair, which uses a special type of electromagnetic technology, is generally safe for treating various conditions. One study found that this technology can safely strengthen pelvic floor muscles, aiding urinary incontinence without causing serious side effects. Another study reported fewer infections and no instances of painful intercourse, indicating that this treatment is safe for users.

While researchers are studying the Emsella Chair for erectile dysfunction, current evidence for its use in other conditions appears promising. Overall, the treatment is well-tolerated with a low risk of side effects, making it a potentially safe option to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for erectile dysfunction, like medications such as Viagra or Cialis, work by enhancing blood flow to the penis. But the Emsella Chair Therapy is different because it uses High-Intensity Focused Electromagnetic (HIFEM) technology. This non-invasive method stimulates pelvic floor muscles, potentially improving erectile function by enhancing muscle strength and nerve function. Researchers are excited about this treatment because it offers a drug-free option that could benefit those who may not respond well to or tolerate medications. Additionally, the treatment is simple, requiring just a short session of sitting on the chair, which could improve patient compliance and convenience.

What evidence suggests that the Emsella Chair is effective for erectile dysfunction?

Research shows that the Emsella Chair might help treat erectile dysfunction. This chair uses High-Intensity Focused Electromagnetic (HIFEM) technology. Studies using HIFEM have shown improvements in sexual function, with patients reporting better sexual desire and erectile function. One study found significant improvements, with noticeable increases in scores related to sexual health. This trial will compare the Emsella Chair Active Treatment, which uses HIFEM technology, with a Sham Treatment that provides some sensation without active HIFEM. Although more research is needed, these early findings are promising for those considering this treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

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 have tried and not benefited from basic treatments like lifestyle changes or pills.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05370651

Emsella Chair vs Sham for Male Sexual Dysfunction 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05370651/emsella-chair-vs-sham-for-male-sexual-dysfunction

Emsella Chair vs Sham for Male Sexual Dysfunction 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8016513/

A Comparative Study on the Effects of High-Intensity ... Treatment Protocol​​ BTL EMSELLA uses HIFEM technology for PFM strengthening and reduction of UI. The device is consisted of a power generator and a circular ...

4. longdom.org longdom.org/open-access-pdfs/improving-male-pelvic-health-efficacy-of-hifem-muscle-stimulation-for-urinary-function-and-sexual-dysfunction-in-men.pdf

Improving Male Pelvic Health: Efficacy of HIFEM Muscle ... Based on the IIEF data evaluation, the patients mainly improved. (P<0.05) in sexual desire, orgasmic function, and erectile dysfunction domains, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026803/

Prospective Comparative Study of EMSella Therapy and ... Post-treatment outcomes revealed significant differences in prolapse reduction, with anterior colporrhaphy showing a superior improvement rate, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6851770/

Safety and Efficacy of a Non‐Invasive High‐Intensity ... This study demonstrated that HIFEM technology can safely and effectively treat stress, urge and mixed urinary incontinence by pelvic floor muscle strengthening.

7. journals.lww.com journals.lww.com/fpmrs/fulltext/2021/04000/a_comparative_study_on_the_effects_of.11.aspx

A Comparative Study on the Effects of High-Intensity Focused The patient's subjective bimodal assessment revealed greater results in group I, which reported reduced incontinence symptoms after the treatments, when ...