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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01317693
• Other study ID #: 0571-10-RMB
• Status: Recruiting
• Phase: Phase 3
• First received: March 8, 2011
• Last updated: December 18, 2012
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2012
• Source: Rambam Health Care Campus
• Contact: Ilan Gruenwald, MD
• Phone: 00972-4-8542882
• Email: i_gruenwald[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Low intensity shock waves
1500 shocks, Energy Density - 0.09 mJ/mm2

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success		13 weeks	No
Secondary	Rigidity Score Questionaire- an increase by at least 1 point is considered success		13 weeks	No