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

Initia1 site in 1 country60 target enrollmentDecember 2012

ConditionsVasculogenic Erectile Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Vasculogenic Erectile Dysfunction
Sponsor: Initia
Enrollment: 60
Locations: 1
Primary Endpoint: Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

February 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Initia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Good general health
•Vasculogenic ED for at least 6 months
•International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
•Positive response to PDE5-I (able to penetrate on demand, Responders)
•Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
•Stable heterosexual relationship for more than 3 months

Exclusion Criteria

•Psychogenic ED
•Neurological pathology
•Hormonal pathology
•Past radical prostatectomy
•Recovering from cancer during last 5 years
•Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
•Clinically significant chronic hematological disease
•Anti-androgens, oral or injectable androgens
•Radiotherapy in pelvic region

Outcomes

Primary Outcomes

Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment

Time Frame: 1, 3 and 6 months post treatment

Secondary Outcomes

Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment(1, 3 and 6 months post treatment)
Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment(1, 3 and 6 months post treatment)