Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01811797

Enrollment

Registered

2013-03-15

Start date

2013-10-31

Completion date

2014-06-30

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

Erectile Dysfunction, Extracorporeal shockwave, Low intensity shockwaves

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.

Interventions

DEVICELow Intensity Shockwave by Renova

DEVICESham treatment

Sham treatment that looks, sounds and feels like the real LISW treatment.

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 * 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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

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