Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

Initia

Status

Completed

Conditions

Vasculogenic Erectile Dysfunction

Treatments

Device: Shockwave system

Device: Sham treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01814852

RENO-006B-MR

Details and patient eligibility

About

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Full description

This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.

Enrollment

60 patients

Sex

Male

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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