Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

Initia

Status

Terminated

Conditions

Vasculogenic Erectile Dysfunction

Treatments

Device: Low Intensity Shockwave by Renova

Device: Sham treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01811797

RENO-03-ICH

Details and patient eligibility

About

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Enrollment

2 patients

Sex

Male

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Good general health
Vascular 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

Hormonal, neurological or psychological pathology
Past radical prostatectomy or extensive pelvic surgery
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
Past radiotherapy treatment of the pelvic region
International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)