Phase
Condition
Men's Health
Erectile Dysfunction
Sexual Dysfunction
Treatment
BTL Emsella Chair
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Able to read, understand, and provide written, dated, informed consent prior toscreening, and be likely to comply with study protocol, including independentlycomplete study questionnaires and communicate with study personnel about adverseevents and other clinically important information.
Men ≥ 18 years of age.
Sexually active within the past 12 weeks and plan to be sexually active during thenext 12 weeks.
Self-reported ejaculatory dysfunction symptoms present >3 months 6. Self-reportedfailed conservative care of behavioral modifications and/or oral medications.
Subject agrees not to start any new treatment for erectile dysfunction orejaculatory dysfunction during the treatment and follow-up periods.
Exclusion
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, especiallyduring exercise; chest pain, such as squeezing, pressure of tightness; the sensationof 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, orbuttocks.
Major metal implants such as: metal plates, screws, joint replacements, implantedcardiac pacemakers, drug pumps, neurostimulators, electronic implants,defibrillators, and metal implants in the pelvic area. Patients with other metalimplants 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 itbefore each treatment
Active urethral diverticula
Known history of urethral stricture disease
Currently healing from surgical procedures where muscle contraction may disrupt thehealing process
Subject is currently receiving treatment for a malignant tumor that would interferewith 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, neurogenicbladder etc.
Current use of neuromodulation therapy, including Interstim and percutaneous tibialnerve 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 orpreviously received an investigational drug or treatment within 30 days of theScreening 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 theeligibility criteria have been left off the list posted while the trial isongoing. A full list of eligibility criteria will be posted upon completion ofthe trial.
Study Design
Study Description
Connect with a study center
Beaumont Hospital Royal Oak
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
United StatesActive - Recruiting
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