Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

Phase 3

• Conditions: Erectile Dysfunction
• Interventions: Device: Low intensity shock waves

• Registration Number: NCT01317693
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-16
• Study First Posted: 2011-03-17
• Primary Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-19
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• ED of more than 6 months
• At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
• Positive response to PDE-5 inhibitors
• IIEF-5 domain score of 12-20 denoting mild to severe ED
• Non-Neurological pathology
• Stable heterosexual relationship for more than 3 months

Exclusion Criteria

• NPT - normal/flat
• Prior prostatectomy surgery
• Any cause of ED other than vascular related
• Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
• Clinically significant chronic hematological disease
• Cardiovascular conditions that prevent sexual activity
• History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
• Cancer within the past 5 years.
• Anti-androgens, oral or injectable androgens
• Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment LI-ESWT	Low intensity shock waves	Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Primary Outcome Measures

Name	Time	Method
Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success	13 weeks

Secondary Outcome Measures

Name	Time	Method
Rigidity Score Questionaire- an increase by at least 1 point is considered success	13 weeks

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel