Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901056
• Other study ID #: ED-ESWT
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 12, 2009
• Last updated: January 23, 2011
• Start date: November 2008
• Est. completion date: March 2010

Study information

• Verified date: November 2010
• Source: Medispec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.

Description:

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 trough the applicator covering the corpora cavernosa of the penis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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:
• Extracorporeal Shockwave Therapy
Energy Density - 0.02 - 0.15 mJ/mm2

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF score		3 months	No
Secondary	Rigid Score (RS)		3 months	No
Secondary	Quality of Erection Questionnaire (QEQ)		3 months	No
Secondary	Self-Esteem And Relationship Questionnaire (SEAR)		3 months	No
Secondary	Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)		3 months	No
Secondary	Side Effects		3 months	Yes