A Pilot Evaluation of the Effect of the Erchonia® HLS™ on Individuals With Erectile Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Erchonia Corporation
- Locations
- 1
- Primary Endpoint
- Total Score on the International Index of Erectile Function - Erectile Function
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Total Score on the International Index of Erectile Function - Erectile Function
Time Frame: 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 Outcomes
- Total Erection Hardness Score(6 week)