Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01814852

Enrollment

Registered

2013-03-20

Start date

2012-12-31

Completion date

2015-02-28

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasculogenic Erectile Dysfunction

Keywords

Low Intensity Shockwave, Extracorporeal shockwave therapy, Erectile dysfunction

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.

Interventions

DEVICEShockwave system

DEVICESham treatment

Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026