Emsella Chair vs Sham for Male Sexual Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCorewell Health East
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BTL Emsella Chair
DeviceSubjects 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%.
Treatment groups
117 Participants
are divided into 2 treatment groupsGroup A: Emsella Chair Active TreatmentActive comparator 1 intervention
Group B: Emsella Chair Sham TreatmentSham comparator 1 intervention
Trial outcomes
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.
Time frame
4 weeks after completing all 8 treatmentsSecondary outcomes
1
Change in subject-reported ability to achieve an erection as measured by the Male Sexual Health Questionnaire (MSHQ) responses.
The MSHQ is a validated, self-administered questionnaire which was developed specifically for assessing key aspects of sexual function and satisfaction in the aging male with urogenital health concerns. Specifically the score for Question 1 will be reviewed from the erection scale. "In the last month, without using drugs like Viagra, how often have you been able to get an erection when you wanted to?" Measured as (5 = all of the time, 4 = most of the time, 3 = about half of the time, 2 = less than half the time, 1 = none of the time, and 0= used Viagra or similar drug with every sexual encounter). A higher score indicates a higher ability to achieve an erection. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.
Time frame
At baseline and 4 weeks after completing the primary endpoint2
Change in subject-reported ability to maintain an erection as measured by MSHQ responses
The MSHQ is a validated, self-administered questionnaire which was developed specifically for assessing key aspects of sexual function and satisfaction in the aging male with urogenital health concerns. Specifically the score from question 2 will be reviewed from the erection scale. "In the last month, if you were able to get an erection without using drugs like Viagra, how often were you able to stay hard as long as you wanted to?" Measured as (5 = all of the time, 4 = most of the time, 3 = about half of the time, 2 = less than half the time, 1 = none of the time, and 0= used Viagra or similar drug with every sexual encounter). A higher score indicates a higher ability to maintain an erection. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.
Time frame
At baseline and 4 weeks after completing the primary endpoint3
Change in subject-reported ability to ejaculate as measured by MSHQ responses
The MSHQ is a validated, self-administered questionnaire which was developed specifically for assessing key aspects of sexual function and satisfaction in the aging male with urogenital health concerns. Specifically the score from question 5 will be reviewed from the ejaculation scale. "In the last month, how often have you been able to ejaculate when having sexual activity?" Measured as (5 = all of the time, 4 = most of the time, 3 = about half of the time, 2 = less than half the time, 1 = none of the time/could not ejaculate). A higher score indicates a higher ability to achieve ejaculation. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.
Time frame
At baseline and 4 weeks after completing the primary endpoint4
Change in subject-reported strength or force of ejaculation as measured by MSHQ
The MSHQ is a validated, self-administered questionnaire which was developed specifically for assessing key aspects of sexual function and satisfaction in the aging male with urogenital health concerns. Specifically the score from question 8 will be reviewed from the ejaculation scale. "In the last month, how would you rate the strength or force of your ejaculation?" Measured as (5 = as strong as it always was, 4 = a little less strong than it used to be, 3 = somewhat less strong then it used to be, 2 = much less strong than it used to be, 1 = very much less strong than it used to be, 0= could not ejaculate). A higher score indicates a higher ability to achieve a forceful ejaculation. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.
Time frame
At baseline and 4 weeks after completing the primary endpointSponsors and contacts
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Source ClinicalTrials.gov