Emsella Chair vs Sham for Male Sexual Dysfunction

NCT05370651 | Recruiting FDA Device

• 1 other identifier: 2022-165
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Male Sexual Dysfunction; Ejaculatory Dysfunction

Keywords

Male Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  The GRA is a validated single question survey prompting subjects to rank change in symptom severity since the start of therapy on a 7-point scale (1 = markedly worse, 2 = moderately worse, 3 = mildly worse, 4 = same, 5= slightly improved, 6 = moderately improved, 7= markedly improved). A score equal to or above 5 will show improvement. A score of 4 will mean no change. A score equal to or below 3 will show worsening of symptoms.

  4 weeks after completing all 8 treatments

Secondary Outcomes (11)

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

  At baseline and 4 weeks after completing the primary endpoint

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

  At baseline and 4 weeks after completing the primary endpoint

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

  At baseline and 4 weeks after completing the primary endpoint

• Change in subject-reported strength or force of ejaculation as measured by MSHQ

  At baseline and 4 weeks after completing the primary endpoint

• Change in subject-reported volume of semen when ejaculating as reported on the MSHQ.

  At baseline and 4 weeks after completing the primary endpoint

Study Arms (2)

Emsella Chair Active Treatment

ACTIVE COMPARATOR

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%.

Device: BTL Emsella Chair

Emsella Chair Sham Treatment

SHAM COMPARATOR

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).

Device: BTL Emsella Chair

Interventions

BTL Emsella Chair DEVICE

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%.

Emsella Chair Active Treatment; Emsella Chair Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must a male, with male genitals
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Self-reported ejaculatory dysfunction symptoms present \>3 months 6. Self-reported failed conservative care of behavioral modifications and/or oral medications.
• \. Subject agrees not to start any new treatment for erectile dysfunction or ejaculatory dysfunction during the treatment and follow-up periods.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

MeSH Terms

Conditions

Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Study Officials

• Kenneth Peters, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo Medado-Ramirez, BSN

CONTACT

248-551-7360; Josephine.Medado-Ramirez@corewellhealth.org

Jennifer Giordano, BSN

CONTACT

248-551-3517; Jennifer.Giordano@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The sham Emsella treatment will provide sensation without active HIFEM technology. The sham treatment amplitude setting will be limited to below the therapeutic level.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: 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 enrolling participants on to phase 2, which is a sham controlled, randomized blinded study. Patients who meet all eligibility criteria will be randomized (2:1) to receive Emsella chair or sham treatments. In phase 2, the subject and biostatistician will be blinded to the group allocation throughout the study. The initial analysis of data, performed by the biostatistician will not include group assignment.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: December 14, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)