Vasculogenic Erectile Dysfunction | Linear Focused Shockwave Treatment for Erectile Dysfunction
Vasculogenic Erectile Dysfunction research study
What is the primary objective of this study?
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.
Who is eligible to participate?
Inclusion Criteria: 1. Good general health 2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years. 3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25 4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors 5. Stable sexual relationship for at least 3 months prior to treatment 6. Minimum of two sexual attempts per month Exclusion Criteria: 1. Hormonal, neurological or psychological pathology 2. Past radical prostatectomy or extensive pelvic surgery 3. Recovering from cancer during last year 4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities 5. Clinically significant chronic hematological disease 6. Anti-androgens, oral or injectable androgens 7. Past radiotherapy treatment of the pelvic region 8. International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Vasculogenic Erectile Dysfunction
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:RenovaLow- Intensity Shockwave
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: March 2014
Completed Date: August 2015
Primary Outcome: IIEF-EF- International Index of Erectile Function questionnaire score
Secondary Outcome: SEP- Sexual Encounter Profile: Questions 2 and 3
Study sponsors, principal investigator, and references
Lead Sponsor: Initia
Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.