NCT01262157

Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study

A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Male
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Detailed description

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Extracorporeal Shockwave Therapy Generator (Vascuspec)	Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
DEVICE	Low intensity shock wave therapy	Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2010-12-17
• Last updated: 2011-05-19

Locations

1 site across 1 country: Israel