Trial Outcomes & Findings for Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain (NCT NCT04248491)

NCT ID: NCT04248491

Last Updated: 2023-09-21

Results Overview

Mean change in Pain VAS from baseline to end of treatment will be compared between the Emsella Chair group and the sham group. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. Value at week 8 minus the value at baseline was used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Baseline and week 8
• Results posted on: 2023-09-21

Participant Flow

Participant milestones

Measure	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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
Overall Study STARTED	6	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Emsella Chair Versus Sham for the Treatment of Chronic Pelvic Pain

Baseline characteristics by cohort

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	54 Years STANDARD_DEVIATION 17 • n=5 Participants	36 Years STANDARD_DEVIATION 13 • n=7 Participants	45 Years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 8

Mean change in Pain VAS from baseline to end of treatment will be compared between the Emsella Chair group and the sham group. VAS is scored from 0-10, where 0 = no pain and 10 = worst possible pain. Value at week 8 minus the value at baseline was used to calculate change. Negative numbers indicate an improvement in pain, and positive numbers indicate a worsening pain.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Pain and Discomfort as Measured by the Visual Analog Scale (VAS)	0.6 units on scale Standard Deviation 1.52	1.6 units on scale Standard Deviation 1.82

SECONDARY outcome

Timeframe: Baseline and week 12

Change in subject-reported impression of CPP severity as measured by the Patient Global Impression of Severity scale (PGI-S). The subject will check the box that describes how their condition is now. This is a four point scale, with 1=normal, 2= mild, 3=moderate, and 4= severe. The value at week 12 minus the value at baseline was calculated. A positive change indicates a worsening condition, and a negative value indicated an improvement in condition.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Impression of CPP Severity as Measured by the Patient Global Impression of Severity Scale (PGI-S).	0.2 units on a scale Standard Deviation 0.45	-0.6 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: at 12 weeks

Subject-reported impression of CPP improvement as measured by the Patient Global Impression of Improvement scale (PGI-I). The scale has 7 points with a lower number indicating improvement: (1=very much better, 2=much better, 3=a little better, 4=no change, 5=a little worse, 6-=much worse, 7= very much worse) to describe their chronic pelvic pain symptoms now versus prior to study treatment. We will report the number of individuals reporting a score of 1 or 2, very much better or much better (significantly improved).

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Number of Participants Reporting Significant Symptom Improvement as Measured by the Patient Global Impression of Improvement Scale (PGI-I)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and week 12

A trained provider will complete a pelvic (women) or rectal (men) exam on subjects. The VAS is a validated questionnaire that assesses pain on a scale from 0 = no pain to 10 = worst possible pain. The subject will provide a pain score from 0 - 10 for each of the 4 quadrants assessed. The average pain score of the 4 quadrants is then calculated. The average pain score ranges from 0 to 10. The value from baseline to secondary endpoint at week 12 is calculated. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Impression of CPP Severity as Measured by Subject-reported Pelvic Floor Tenderness to Palpation During 4 Quadrant Pelvic Examination as Measured by VAS.	-0.05 units on a scale Standard Deviation 1.39	1.45 units on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 4 females were enrolled in the study. One was randomized to active treatment, 3 were randomized to sham treatment

The change in CPP severity as measured by subject-reported sexual function as measured by the Female Sexual Function Index questionnaire (FSFI) for female subjects. The FSFI is a 19 question survey. A lower score is equivalent to a higher degree of sexual dysfunction. Scores range from 0 to 36. The change value is calculated from baseline to week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=1 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=3 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Impression of CPP Severity in Females.	-2.20 score on a scale Standard Deviation 0	0.37 score on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: Baseline and week 12

Population: A total of 6 males were enrolled in the study. 4 were randomized to active treatment, 2 were randomized to sham treatment

The change in CPP severity as measured by subject-reported sexual function as measured by the Brief Sexual Function Inventory questionnaire (BSFI) for male subjects. The BSFI is a validated questionnaire for male sexual function. Average score ranges from 0 to 44. A lower score indicates a higher degree of dysfunction. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms. Calculated from the value at week 12 minus value at baseline

Outcome measures

Measure	Emsella Chair Active Treatment n=4 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=2 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Impression of CPP Severity in Males.	0.575 score on a scale Standard Deviation 0.46	-0.10 score on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline and week 12

The Beck Depression Inventory is a 21-question multiple-choice self-report inventory. It is composed of items relating to symptoms of depression such as hopelessness, irritability, guilt, fatigue, weight loss, and lack of interest in sex. Subjects that score greater than 30 at any time may be referred for psychological evaluation but may continue study participation. A higher score indicates a greater severity of depression. Scores can range from 0 to 63. The value of change calculated from baseline minus week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Depression Severity as Measured by the Beck Depression Inventory (BDI).	-3.6 score on a scale Standard Deviation 7.5	3.0 score on a scale Standard Deviation 5.74

SECONDARY outcome

Timeframe: Baseline and week 12

Since both overactive bladder (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS) share urinary urgency and frequency symptoms, this validated measure will evaluate additional aspects associated with OAB and IC/BPS. The OAB-Q Short Form (SF) consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal. Scores can range from 0 to 100. The change value is calculated from the baseline value minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Bother Related to Overactive Bladder Symptoms as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-Q).	7.33 score on a scale Standard Deviation 10.38	7.33 score on a scale Standard Deviation 10.90

SECONDARY outcome

Timeframe: Baseline and week 12

IC/BPS patients can share urinary urgency and frequency symptoms. The ICSI-PI measures urinary and pain symptoms and assesses how problematic are. A higher score indicates greater severity of symptoms. Scores range from 0-36. The change is calculated by the baseline value minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Urinary and Pain Symptoms, as Well as Bother, as Measured by the Interstitial Cystitis Symptom Index and Problem Index (ICSI-PI).	2.2 score on a scale Standard Deviation 1.79	1.2 score on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: Baseline and week 12

The GAD-7 questionnaire is a 7-item validated scale to assess generalized anxiety disorder. Patients are grouped by GAD score 0-7 and 8+ which suggests no anxiety disorder and probably anxiety disorder, respectively. Scores can range from 0 to 21. The change is calculated as the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Anxiety Symptoms as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7).	-1.2 score on a scale Standard Deviation 4.76	-1.8 score on a scale Standard Deviation 1.79

SECONDARY outcome

Timeframe: Baseline and week 12

The McGill Pain Questionnaire can be used to evaluate a person experiencing pain over time to determine the effectiveness of an intervention. The questionnaire consists of 22 questions. Each question is scored 0 (none) to 10 (worst possible). A higher score indicates more severe pain symptoms. Scores range from 0 to 220. The change calculated from the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Pain as Measured by the McGill Pain Questionnaire (MPQ).	8.8 score on a scale Standard Deviation 22.11	5.2 score on a scale Standard Deviation 12.07

SECONDARY outcome

Timeframe: Baseline and week 12

The Pain Catastrophizing Scale (PCS) lists thirteen statements describing different thoughts and feelings that may be associated with pain. Each statement is rated as: 0 =not at all, 1= to a slight degree, 2= to a moderate degree, 3= to a great degree, and 4= all the time. Subjects who report a larger number associated with such thoughts during pain are more likely to rate the pain as more intense. Scores range from 0 to 52. The change is calculated as the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Change in Subject-reported Rumination, Magnification, and Helplessness Related to Pain as Measured by the Pain Catastrophizing Scale (PCS).	3.6 score on a scale Standard Deviation 11.06	-0.6 score on a scale Standard Deviation 5.68

SECONDARY outcome

Timeframe: Week 12

The GRA is a 7-point scale to evaluate the subject's perception of overall improvement in pain. It is scored as follows: 1 = markedly worse, 2 = moderately worse, 3 = mildly worse, 4 = same (unchanged), 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved. The number of participants reporting significant improvement in pain (score of 6 or 7) at week 12 are counted.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
The Subject-reported Perception of Overall Improvement in Pain as Measured by Global Response Assessments (GRA) for Pain and Quality of Life.	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and week 12

Change in subject reported pain and discomfort as measured by the Visual Analog Scale (VAS). The VAS is a validated questionnaire that assesses pain on a scale from 0= no pain to 10= worst possible pain. The change is calculated from the value at baseline minus the value at week 12. Positive change indicates improvement of symptoms. A negative change indicates worsening of symptoms.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
Change in Subject-reported Pain and Discomfort as Measured by VAS	-0.2 score on a scale Standard Deviation 0.84	0.8 score on a scale Standard Deviation 2.05

SECONDARY outcome

Timeframe: From baseline to week 12

Safety and tolerability of the Emsella chair compared to Sham will be assessed as the number of adverse events reported that were determined to be related to the Emsella chair treatment.

Outcome measures

Measure	Emsella Chair Active Treatment n=5 Participants 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 Participants 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
Safety and Tolerability Will be Assessed as the Number of Esmella Chair-related With Adverse Events.	0 Adverse events	0 Adverse events

Adverse Events

Emsella Chair Active Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Emsella Sham Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Emsella Chair Active Treatment n=5 participants at risk 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%. BTL Emsella chair: 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 with every treatment until the subject reaches 100%.	Emsella Sham Treatment n=5 participants at risk 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). BTL Emsella chair: 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 with every treatment until the subject reaches 100%.
Infections and infestations Covid infection	0.00% 0/5 • 12 weeks	40.0% 2/5 • Number of events 2 • 12 weeks
Infections and infestations Vaginal yeast infection	0.00% 0/5 • 12 weeks	20.0% 1/5 • Number of events 1 • 12 weeks
Injury, poisoning and procedural complications Testicular injury	20.0% 1/5 • Number of events 1 • 12 weeks	0.00% 0/5 • 12 weeks

Additional Information

Director Urology Research

Beaumont Health

Phone: 2485511488

Email: bernadette.zwaans@Corewellhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place