NCT03518983

Low-intensity Shockwaves Therapy for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction

Low-intensity Shockwaves Therapy: Validation of an Evidence Based Protocol in a Randomized, Sham-controlled Trial for the Treatment of Patients With Moderate Vasculogenic Erectile Dysfunction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, sham-controlled randomized, 2 parallel arms, clinical trial with a 12-month recruitment period. All patients will be PDE5I users/responders. After 1 month wash-out period, ED patients will be screened, in order to randomize 70 men with vasculogenic ED.Patients will be randomized in 2 groups (35 subjects in each group) to receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks) either at energy level 7 or at sham-control , without treatment interval. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DEVICE	Dornier Aries2 device	The Dornier Aries2 device and will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft and the 2 crura(two sites).
DEVICE	Dornier Aries2 device (sham probe)	The Dornier Aries2 device and will be used for the purpose of the study but the active probe will be replaced by an identical sham probe.

Timeline

• Start date: 2018-05-22
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2018-05-08
• Last updated: 2022-05-05

Locations

1 site across 1 country: Greece