Completed
A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction
What is being tested
Shockwave system
+ Sham treatment
Device
Who is being recruted
Urogenital Diseases+5
+ Genital Diseases
+ Mental Disorders
From 20 to 80 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-Controlled
Interventional
Study Start: December 2012
Summary
Principal SponsorInitia
Last updated: May 12, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2012
Actual date on which the first participant was enrolled.This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.
Principal SponsorInitia
Last updated: May 12, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 20 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesMental DisordersGenital Diseases, MaleSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMale Urogenital DiseasesErectile Dysfunction
Criteria
6 inclusion criteria required to participate
Good general health
International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
Positive response to PDE5-I (able to penetrate on demand, Responders)
Show More Criteria
9 exclusion criteria prevent from participating
Anti-androgens, oral or injectable androgens
Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
Clinically significant chronic hematological disease
Hormonal pathology
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental4 weekly sessions of low-intensity shockwave therapy
Group II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center