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The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Evidence of co-existing Neurological disease or other systemic disease conditions such as Alzheimer or Parkinson disease which affects erectile function (at the discretion of the investigator)
History of radical prostatectomy or extensive pelvic surgery ever
Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
Anatomical malformation of the penis, including Peyronie's disease.
Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
Diabetes type I
Diabetes Type II with A1C level > 8.5% within 1 month prior to enrollment.
Unwillingness to abstain from systemic medications known to cause ED for the study duration.
Internal defibrillator, pacemaker or any other implanted electrical device anywhere in the body
Permanent metal implant in the treatment area
Any surgery in the treatment area in the last 3 months
Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles in the facial area
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction
Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes and rash.
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
Use of Isotretinoin (Accutane®) within 30 days prior to treatment.
Participation in another study within 30 days prior to screening.
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
MEITAL MATALON; Maria Shusterman
Data sourced from clinicaltrials.gov
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