NCT01274156

Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction

The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Male
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Detailed description

This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	"MEDISPEC" treatment probe	300 shocks in 5 different anatomical locations of the penis.
DEVICE	"MEDISPEC" Sham Probe	Sham probe applied same as treatment probe without energy
DEVICE	"MEDISPEC" Low intensity shock waves	Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min
DEVICE	Sham	Probe does not deliver energy but creates same noise and sensation of active probe

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2011-01-11
• Last updated: 2011-01-11

Locations

1 site across 1 country: Israel