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
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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