Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction (LISW)

Initia

Status: Completed

Conditions: Vasculogenic Erectile Dysfunction

Treatments: Device: Low intensity linear focused shockwave device ('Renova')

Study type: Observational

Funder types: Industry

Identifiers

NCT02005731

LSWT-004-EU

Details and patient eligibility

About

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

Enrollment: 58 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

Trial design

58 participants in 1 patient group

Shockwaves

Description:

Low intensity linear focused shockwave device ('Renova')

Treatment:

Device: Low intensity linear focused shockwave device ('Renova')