Low Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: Standardisation of Treatment Protocol

NCT03089294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-03-26

No results posted yet for this study

Summary

The present study aims to identify the efficacy saturation effect of low intensity extracorporeal shockwave treatment (LI-ESWT) using Aries ED device in men with mild-moderate and severe vasculogenic ED, who have previously responded to oral PDE5-Is. The efficacy and safety of 4 different session frequency protocols will be compared.

Conditions

Interventions

DEVICE

Aries ED device

The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)

Sponsors & Collaborators

  • Institute for the Study of Urological Diseases, Greece

    lead OTHER

Principal Investigators

  • Dimitrios Hatzichristou, Prof. · Institute for the Study of Urological Diseases (ISUD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-30
Primary Completion
2018-06-06
Completion
2018-12-10

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03089294 on ClinicalTrials.gov