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

Medispec1 site in 1 country20 target enrollmentNovember 2008

ConditionsErectile Dysfunction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Medispec
Enrollment: 20
Locations: 1
Primary Endpoint: IIEF score
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

March 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Medispec

Eligibility Criteria

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