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

Rambam Health Care Campus

Status and phase: Unknown; Phase 3

Conditions: Erectile Dysfunction

Treatments: Device: Low intensity shock waves

Study type: Interventional

Funder types: Other

Identifiers

NCT01317693

0571-10-RMB

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Treatment LI-ESWT

Experimental group

Description:

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.

Treatment:

Device: Low intensity shock waves