Emsella Chair vs Sham for Male Sexual Dysfunction

Study Overview
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Brief Summary
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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 total of 114 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
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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 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.

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

Conditions
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Male Sexual Dysfunction, Ejaculatory Dysfunction

Intervention / Treatment
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* Device: BTL Emsella Chair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 (1:1) 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Emsella Chair Active Treatment<br>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<br>* Subjects will sit on the device. The RNC 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%.<br>|
| Sham Comparator: Emsella Chair Sham Treatment<br>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<br>* Subjects will sit on the device. The RNC 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%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the 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). | 4 weeks after completing all treatments; week 8 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subject-reported ability to achieve an erection as measured by the Male Sexual Health Questionnaire (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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 1 will be reviewed from the erection scale. 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. | 4 weeks after completing the primary endpoint; week 12 of the study | 
| 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 2 will be reviewed from the erection scale. 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. | 4 weeks after completing the primary endpoint; week 12 of the study | 
| 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 5 will be reviewed from the ejaculation scale. 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. | 4 weeks after completing the primary endpoint; week 12 of the study | 
| 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 8 will be reviewed from the ejaculation scale. Measured as (5 = as strong as it always wast, 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. | 4 weeks after completing the primary endpoint; week 12 of the study | 
| Change in subject-reported volume of semen when ejaculating as reported on the 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 9 will be reviewed from the ejaculation scale. Measured as (5 = as much as it always was time, 4 = a little less then it used to be, 3 = somewhat less than it used to be, 2 = much less than it used to be, 1 = very much less than it used to be, 0= could not ejaculate). A higher score indicates a higher ability to produce a greater volume of ejaculate. | 4 weeks after completing the primary endpoint; week 12 of the study | 
| Change in subject-reported pleasure with ejaculation as measured by the 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 10 will be reviewed from the ejaculation scale. Measured as (5 = increased a lot, 4 = increased moderately, 3 = neither increased nor decreased, 2 = decreased moderately, 1 = decreased a lot, 0= could not ejaculate). A higher score indicates a higher ability report pleasure with ejaculation. | 4 weeks after completing the primary endpoint; week 12 of the study | 
| Change in subject-reported pain with ejaculation as measured by the 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 11 will be reviewed from the ejaculation scale. Measured as (5 = no pain at all, 4 = slight amount of pain or discomfort, 3 = moderate amount of pain or discomfort, 2 = strong amount of pain or discomfort, 1 = extreme amount of pain or discomfort, 0= could not ejaculate). A higher score indicates no pain or less pain with ejaculation. | 4 weeks after the primary endpoint visit; week 12 of the study | 
| Change in subject-reported satisfaction with sex life as measured by the 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 14 will be reviewed from the satisfaction scale. Measured as (5 = extremely satisfied, 4 = moderately satisfied, 3 = neither satisfied nor unsatisfied, 2 = moderately unsatisfied, 1 = extremely unsatisfied). | 4 weeks after the primary endpoint visit; week 12 of the study | 
| Change in subject-reported urge or desire to have sex as measured by the 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. The MSHQ contains 3 domains: Erection scale (3 items), Ejaculation scale (7 items), and Sexual satisfaction scale (6 items). 9 additional items (2 items measuring bothersome linked to erection and ejaculation and 7 items measuring sexual activity and desire). Specifically item 22 will be reviewed. Measured as (5 =all the time, 4 = most of the time, 3 = about half of the time, 2 = less than half of the time, 1 = none of the time). | 4 weeks after the primary endpoint visit; week 12 of the study | 
| The secondary durability objective for this study is to determine whether subjects in the Emsella Chair group continue to have a higher responder rate, as measured by the GRA, compared to the Sham group 4 weeks after the primary efficacy endpoint. | 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). | Treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study | 
| 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. | Safety and tolerability of the Emsella chair compared to Sham will be assessed in relation to the incidence of adverse events reported related to the device. | 4 weeks after the primary endpoint; week 12 of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Sexual Dysfunction