114 Participants Needed

Emsella Chair Therapy for Erectile Dysfunction

(Emsella_EJD Trial)

Recruiting at 1 trial location
JG
LV
AS
KP
Overseen ByKenneth Peters, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

Dr. Kenneth M Peters, MD - Royal Oak ...

Kenneth M Peters, MD

Principal Investigator

Beaumont Hospital Royal Oak

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.
See 2 more

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.
See 13 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: Emsella Chair Active TreatmentActive Control1 Intervention
Group II: Emsella Chair Sham TreatmentPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as BTL Emsella Chair for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Beaumont Hospitals

Lead Sponsor

Trials
153
Recruited
113,000+

Published Research Related to This Trial

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

Citations

[Vacuum therapy for erectile dysfunction that fails to respond to PDE-5i: report of 70 cases]. [2013]
Low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction after penile trauma. [2020]
[Erectile dysfunction from a urological perspective]. [2018]
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]
Current paradigms in treating erectile dysfunction. [2015]
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