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

Not Applicable

Completed

• Conditions: Vasculogenic Erectile Dysfunction

• Registration Number: NCT01814852
• Lead Sponsor: Initia

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-18
• Study First Posted: 2013-03-20
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel