Emsella Chair vs Sham for Male Sexual Dysfunction

Conditions

• Ejaculatory Dysfunction
• Male Sexual Dysfunction

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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%.

Study 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 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.

Key Dates

Start date

Dec 14, 2022

Status verified

Dec 2025

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

117 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Emsella Chair Active Treatment
  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%.
• Sham Comparator: Emsella Chair Sham Treatment
  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).

Primary Outcome Measure

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 ]

Central Contacts

• Jo Medado-Ramirez, BSN
  248-551-7360
  [email protected]
• Jennifer Giordano, BSN
  248-551-3517
  [email protected]

Locations (1)

Find similar trials in Royal Oak, MI

Related Studies

• Ejaculatory and Orgasmic Dysfunction Registry
  Recruiting · Charitable Union for the Research and Education of Peyronie's Disease · Orem, Utah