What side effects are associated with this type of intervention?

Common treatments for premature ejaculation include pharmacologic options like selective serotonin reuptake inhibitors (SSRIs) and topical anesthetics, as well as behavioral therapies. SSRIs can cause side effects such as nausea, dizziness, drowsiness, and sexual dysfunction. Topical anesthetics may lead to temporary loss of sensitivity and potential allergic reactions. Electromagnetic stimulation, similar to the Emsella Chair, is being studied for its efficacy and safety, with mild side effects reported such as warmth, numbness, and tingling in the treated area.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for premature ejaculation that utilize electromagnetic stimulation like the Emsella Chair. The primary FDA-approved pharmacologic treatments for premature ejaculation include topical anesthetics such as lidocaine-prilocaine cream and oral medications like selective serotonin reuptake inhibitors (SSRIs), including dapoxetine, which is not FDA-approved in the United States but is used in other countries. Behavioral therapies and counseling are also commonly recommended.

What other types of research exist?

Promising alternatives to the Emsella Chair for treating premature ejaculation include: 1) Phosphodiesterase-5 (PDE5) inhibitors, which have shown efficacy in treating erectile dysfunction and may benefit premature ejaculation. 2) Cognitive Behavioral Therapy (CBT), which addresses psychological factors contributing to premature ejaculation. 3) Acupuncture, which has been effective in treating various urological chronic pain syndromes and may offer benefits for premature ejaculation. 4) Topical anesthetics, which can reduce penile sensitivity and delay ejaculation.

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Electromagnetic Technology

Emsella Chair Therapy for Erectile Dysfunction (Emsella_EJD Trial)

Q: What is the mechanism of action of this treatment?

The Emsella Chair uses electromagnetic stimulation to induce pelvic floor muscle contractions, which can strengthen these muscles and improve control over ejaculation. This is particularly relevant for Premature Ejaculation (PE) patients as stronger pelvic floor muscles can help delay ejaculation and improve sexual performance. Other common treatments for PE include selective serotonin reuptake inhibitors (SSRIs) and topical anesthetics. SSRIs work by increasing serotonin levels in the brain, which can delay ejaculation, while topical anesthetics reduce penile sensitivity, thereby prolonging the time to ejaculation. These treatments are important as they address different aspects of PE, providing multiple options for patients to manage their condition effectively.

N/A

Recruiting

Led By Kenneth Peters, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Men ≥ 18 years of age.

Must not have

Active urethral diverticula.

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 weeks, up to 24

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort due to muscle contractions from the chair's electromagnetic field and possible skin irritation at contact points. Any adverse events related to underlying excluded conditions such as metal implants causing interference would also be considered side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am a man aged 18 or older.

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I have had issues with ejaculation for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active urethral diverticulum.

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I haven't used neuromodulation therapy for bladder issues in the last 3 months.

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I have sexual dysfunction due to a neurological condition like MS or spinal injury.

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I cannot feel my pelvis, thigh, or buttocks normally.

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I have a piercing between my waist and knees and won't remove it for treatment.

Select...

I am not currently receiving treatment for another cancer that would affect my participation in the study.

Select...

I have used Botox in my bladder or pelvic floor muscles within the last year.

Select...

I have a history of urethral stricture disease.

Select...

I experience significant breathing problems, chest pain, heart palpitations, swelling in legs or feet, dizziness, fainting, or have bluish nails/lips.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 weeks, up to 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 weeks, up to 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 weeks, up to 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The overall efficacy of the Emsella Chair to sham by evaluating subject reported symptom improvement as measured by the Global Response Assessment (GRA)

Secondary study objectives

Change in subject-reported ability to achieve an erection as measured by the Male Sexual Health Questionnaire (MSHQ) responses.

Change in subject-reported ability to ejaculate as measured by MSHQ responses

Change in subject-reported ability to maintain an erection as measured by MSHQ responses

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Emsella Chair Active TreatmentActive Control1 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 TreatmentPlacebo Group1 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).

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Emsella Chair uses electromagnetic stimulation to induce pelvic floor muscle contractions, which can strengthen these muscles and improve control over ejaculation. This is particularly relevant for Premature Ejaculation (PE) patients as stronger pelvic floor muscles can help delay ejaculation and improve sexual performance. Other common treatments for PE include selective serotonin reuptake inhibitors (SSRIs) and topical anesthetics. SSRIs work by increasing serotonin levels in the brain, which can delay ejaculation, while topical anesthetics reduce penile sensitivity, thereby prolonging the time to ejaculation. These treatments are important as they address different aspects of PE, providing multiple options for patients to manage their condition effectively.