Emsella Chair Active Treatment for Erectile Dysfunction
Phase-Based Progress Estimates
Effectiveness
Safety
Beaumont Hospital-Royal Oak, Royal Oak, MI
Erectile Dysfunction+1 More
BTL Emsella Chair - DeviceEligibility
18+
Male
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Eligibility
18+
Male
What conditions do you have?
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Study Summary
The purpose of this clinical trial is to compare Emsella Chair therapy to Sham and determine whether electromagnetic technology is effective in the treatment of male sexual dysfunction. Currently there are no other studies utilizing the Emsella chair for the treatment of male sexual dysfunction. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.
Eligible Conditions
- Erectile Dysfunction
- abnormal ejaculation
Treatment Effectiveness
Effectiveness Progress
Other trials for Erectile Dysfunction
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: 4 weeks after the primary endpoint; week 12 of the study
Week 8
Compare the efficacy of the Emsella Chair to sham by evaluating subject reported symptom improvement as measured by the Global Response Assessment (GRA)
Week 12
Change in subject-reported ability to achieve an erection as measured by the Male Sexual Health Questionnaire (MSHQ).
Change in subject-reported ability to ejaculate as measured by MSHQ responses
Change in subject-reported ability to maintain an erection as measured by MSHQ responses
Change in subject-reported pleasure with ejaculation as measured by the MSHQ.
Change in subject-reported strength or force of ejaculation as measured by MSHQ
Change in subject-reported volume of semen when ejaculating as reported on the MSHQ.
Week 12
Change in subject-reported pain with ejaculation as measured by the MSHQ.
Change in subject-reported satisfaction with sex life as measured by the MSHQ.
Change in subject-reported urge or desire to have sex as measured by the MSHQ.
Week 12
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.
Week 12
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.
Trial Safety
Safety Progress
Other trials for Erectile Dysfunction
Trial Design
2 Treatment Groups
Emsella Chair Active Treatment
1 of 2
Emsella Chair Sham Treatment
1 of 2
Active Control
Non-Treatment Group
114 Total Participants · 2 Treatment Groups
Primary Treatment: Emsella Chair Active Treatment · Has Placebo Group · N/A
Emsella Chair Sham Treatment
Device
ShamComparator Group · 1 Intervention: BTL Emsella Chair · Intervention Types: DeviceEmsella Chair Active Treatment
Device
ActiveComparator Group · 1 Intervention: BTL Emsella Chair · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks after the primary endpoint; week 12 of the study
Trial Background
Kenneth M Peters, MD
Principal Investigator
William Beaumont Hospitals
Closest Location: Beaumont Hospital-Royal Oak · Royal Oak, MI
2019First Recorded Clinical Trial
1 TrialsResearching Erectile Dysfunction
4 CompletedClinical Trials
Eligibility Criteria
Age 18+ · Male Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are 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.
You are sexually active within the past 12 weeks and plan to be sexually active during the next 12 weeks.
Self-reported erectile or ejaculatory dysfunction symptoms present >3 months.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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