Emsella Chair vs Sham for Male Sexual Dysfunction

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.

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.

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.

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.

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.

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 9 will be reviewed from the ejaculation scale. "In the last month, how would you rate the amount or volume of semen when you ejaculate?" 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. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.

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 10 will be reviewed from the ejaculation scale. "Compared to ONE month ago, would you say the physical pleasure you feel when you ejaculate has-" 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. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.

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 11 will be reviewed from the ejaculation scale. "In the last month, have you experienced any physical pain or discomfort when you ejaculated? Would you say you have…" 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. Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.

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 the score from question 14 will be reviewed from the sexual satisfaction scale. "Generally, how satisfied are you with the quality of the sex life you have with your main partner?" Measured as (5 = extremely satisfied, 4 = moderately satisfied, 3 = neither satisfied nor unsatisfied, 2 = moderately unsatisfied, 1 = extremely unsatisfied). Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.

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 question 22 will be reviewed, concerning the sexual urges they have felt toward their main partner, and not whether they actually had sex. "In the last month, how often have you felt an urge or desire to have sex with your main partner?" 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). Change from baseline is reported, with a positive number indicating a worsening and a negative number indicating improvement.

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 higher score indicates a better outcome.

Adverse event monitoring will occur between start of treatment to the end of study participation, approximately 12 weeks including the last follow-up visit of the blinded portion. Those randomized to the sham treatment will be offered active treatment after the secondary endpoint visit is completed. Those that elect to receive active treatment will be monitored for adverse events through the last follow-up visit, events during this timeframe will be considered active Emsella Chair.