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

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Low intensity shock waves


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment LI-ESWT<br>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. | Device: Low intensity shock waves<br>* 1500 shocks, Energy Density - 0.09 mJ/mm2<br>* Other names: Omnispec model ED1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rigidity Score Questionaire- an increase by at least 1 point is considered success |  | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LI-ESWT, Erectile Dysfunction, ED, Shock waves, Therapy