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

Not Applicable

Terminated

• Conditions: Vasculogenic Erectile Dysfunction
• Interventions: Device: Low Intensity Shockwave by Renova; Device: Sham treatment

• Registration Number: NCT01811797
• Lead Sponsor: Initia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-15
• Study Start: 2013-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Intensity Shockwave treatment	Low Intensity Shockwave by Renova	4 weekly sessions of Low Intensity Shockwave treatment.
Control group	Sham treatment	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel