Erectile Dysfunction
Conditions
Brief summary
This study is to see if applying low-level laser light can provide improvement in erectile dysfunction
Detailed description
The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing improvement in erectile dysfunction.
Interventions
DEVICEErchonia HLS
84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male between 40 and 80 years old * Known or suspected vasculogenic ED based on clinical history * In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment * Suffering from ED for at least 6 months * Testosterone level between 300 - 1000ng/dL within one month prior to enrollment * Hgb A1C less than or equal to 8% within one month prior to enrollment * Total IIEF-EF scores between 8-25 * EHS score greater than or equal to
Exclusion criteria
* ED due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment * Men with known neurogenic or psychogenic ED * Anatomic malformations of the penis including Peyronie's disease * Testosterone greater than 300ng/dL or 1000ng/dL * Hgb A1C greater than 8% * International Normalized Ratio greater than 2.5, and men on any blood thinners other than 81mg aspirin * Active testicular or prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score on the International Index of Erectile Function - Erectile Function | 6 week | The International Index of Erectile Function - Erectile Function ( domain score is a patient questionnaire (six questions) used to measure various aspects of erectile performance and assess disease severity in efficacy trials concerning ED. The International Index of Erectile Function - Erectile Function has a minimum score of 0 and max of 30, higher scores mean a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Erection Hardness Score | 6 week | The Erection Hardness Score is a single-item scale that has demonstrated good psychometric properties for assessing erectile function in patients. The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. The Total Erection Hardness Score has a minimum possible score of 0 and max of 4, higher scores mean a better outcome |
Countries
United States
Outcome results
None listed