Emsella Chair vs Sham for Male Sexual Dysfunction

Official title

A Single-Blind, Randomized Study of the BTL Emsella Chair Versus Sham for the Treatment of Male Sexual Dysfunction

Overview

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 a total of 117 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.

Detailed 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.

Interventions

• Device BTL Emsella Chair
  Subjects will sit on the device. The clinical research coordinator will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased until the subject reaches 100%.

Primary outcome measures

• The overall efficacy of the Emsella Chair to sham by evaluating subject reported symptom improvement as measured by the Global Response Assessment (GRA) [Time frame: 4 weeks after completing all 8 treatments]

Secondary outcome measures (11)

• Change in subject-reported ability to achieve an erection as measured by the Male Sexual Health Questionnaire (MSHQ) responses. [Time frame: At baseline and 4 weeks after completing the primary endpoint]
• Change in subject-reported ability to maintain an erection as measured by MSHQ responses [Time frame: At baseline and 4 weeks after completing the primary endpoint]
• Change in subject-reported ability to ejaculate as measured by MSHQ responses [Time frame: At baseline and 4 weeks after completing the primary endpoint]
• Change in subject-reported strength or force of ejaculation as measured by MSHQ [Time frame: At baseline and 4 weeks after completing the primary endpoint]
• Change in subject-reported volume of semen when ejaculating as reported on the MSHQ. [Time frame: At baseline and 4 weeks after completing the primary endpoint]
• Change in subject-reported pleasure with ejaculation as measured by the MSHQ. [Time frame: At baseline and 4 weeks after completing the primary endpoint]
• Change in subject-reported pain with ejaculation as measured by the MSHQ. [Time frame: At baseline and 4 weeks after the primary endpoint visit]
• Change in subject-reported satisfaction with sex life as measured by the MSHQ. [Time frame: At baseline and 4 weeks after the primary endpoint visit]
• Change in subject-reported urge or desire to have sex as measured by the MSHQ. [Time frame: At baseline and 4 weeks after the primary endpoint visit]
• The secondary durability objective for this study is to determine whether subjects in the Emsella Chair group continue to have a higher responder rate, compared to the Sham group, as measured by the GRA. [Time frame: 4 weeks after the primary endpoint visit]
• The secondary safety objective of this study are to determine the safety and tolerability of the Emsella Chair compared to Sham. Safety and tolerability will be assessed in relation to the incidence of adverse events. [Time frame: Approximately 12 weeks, up to 24]

Eligibility criteria

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.
• Men ≥ 18 years of age.
• Sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.

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

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

Exclusion criteria

• Botox® use in bladder or pelvic floor muscles in the past year
• Subject weighs greater than 330 pounds, due to weight limits of the Emsella Chair.
• Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure of tightness; the sensation of 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)
• Any condition that causes a lack of normal skin sensation to the pelvis, thigh, or buttocks.
• Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study.
• Previous or current penile prosthesis.
• Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
• Active urethral diverticula
• Known history of urethral stricture disease
• Currently healing from surgical procedures where muscle contraction may disrupt the healing process
• Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
• Subject has used the BTL EMSELLA device previously
• Subject has sexual dysfunction of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy, neurogenic bladder etc.
• 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)
• Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit
• 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 the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Corewell Health William Beaumont University Hospital — Royal Oak

Identifiers

NCT: NCT05370651 · 2022-165

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗