Vasculogenic Erectile Dysfunction
Conditions
Keywords
Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction
Brief summary
This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Interventions
DEVICELow intensity linear focused shockwave device ('Renova')
Sponsors
Initia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Good general health * Vasculogenic ED for at least 6 months * International Index of Erectile Function 6 (IIEF-EF) between 11 to 25 * Positive response to PDE5-I (able to penetrate on demand, Responders) * Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders) * Stable heterosexual relationship for more than 3 months
Exclusion criteria
* Psychogenic ED * Neurological pathology * Hormonal pathology * Past radical prostatectomy * Recovering from cancer during last 5 years * Any unstable medical, psychiatric, spinal cord injury and penile anatomical - abnormalities * Clinically significant chronic hematological disease * Anti-androgens, oral or injectable androgens * Radiotherapy in pelvic region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
Countries
Czechia, Lithuania, Netherlands, Palestinian Territories
Outcome results
None listed