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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Treatment | Experimental | Eligible subjects will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device treatment | Device | 20 heterosexual males clinically diagnosed with Erectile Dysfunction will receive 6 weekly treatments with the Forma Applicator according to the study protocol and will return for two follow up visits 1- and 3-months post treatment. Two further telephone feedback checks will be carried out 6 months and 12 months following the last treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ED symptoms, following the RF treatment | Change in ED symptoms, following the RF treatment measured by THE INTERNATIONAL INDEX OF ERECTILE FUNCTION - ERECTILE FUNCTION (IIEF-EF) questionnaire score. The IIEF-5 score is the sum of the ordinal responses to the 5 items.(1 to 5 ) 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sexual activity leading to optimal penetration | Change in sexual activity leading to optimal penetration measured by SEP- Sexual Encounter Profile questionnaire. The SEP questionnaire consists of 5 items addressing the sexual events and subject experiences when attempting intercourse. Efficacy of RF treatment evaluated using the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Questions 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring pain level during the procedure | NPRS is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | During the procedure |
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.
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20 heterosexual males clinically diagnosed with Erectile Dysfunction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MEITAL MATALON | Contact | 9492396522 | meital.matalon@inmodemd.com | |
| Maria Shusterman | Contact | 9492396522 | maria.shusterman@inmodemd.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert Valenzuela, MD | Principal Investigator | |
| Lanna Cheuck, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LC Medical 140 W 58th St, Suite A New York, NY 10019 | Recruiting | New York | New York | 10019 | United States |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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Prospective, open-label clinical study.
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| 3 months |
| Evaluate efficacy of the RF treatment for erectile function | Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'. | 3 months |
| Evaluate efficacy of the RF treatment for erectile function | Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'. | 6 months |
| Evaluate efficacy of the RF treatment for erectile function | Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'. | 12 months |
| Evaluate efficacy of the RF treatment for hardness of erection | To assess the effectiveness of RF treatment for erectile dysfunction with the Erectile Hardness Score (EHS) questionnaire The Erection Hardness Score is a self-reported tool that measures the hardness of an erection. It involves a scale report from 0 to 4, 4 being the best quality of erection. | 3 months |
| Washington Heights Urology | Recruiting | New York | New York | 10032 | United States |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |