A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova

Initia1 site in 1 country2 target enrollmentOctober 2013

ConditionsVasculogenic Erectile Dysfunction

Overview

Phase: N/A
Intervention: Not specified
Conditions: Vasculogenic Erectile Dysfunction
Sponsor: Initia
Enrollment: 2
Locations: 1
Primary Endpoint: Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
Status: Terminated
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 comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

June 2014

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
•Vascular 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

•Hormonal, neurological or psychological pathology
•Past radical prostatectomy or extensive pelvic surgery
•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
•Past radiotherapy treatment of the pelvic region
•International normalized ratio (INR) \> 3 for patients using blood thinners (such as Coumadin)

Outcomes

Primary Outcomes

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

Time Frame: 1, 3 and 6 months post treatment

Secondary Outcomes

Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment(1, 3 and 6 months post treatment)
Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment(0 and 6 months post treatment)