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

Phase 3

• Conditions: Erectile Dysfunction

• 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

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