Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

Study Overview
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Brief Summary
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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
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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 trough the applicator covering the corpora cavernosa of the penis.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Extracorporeal Shockwave Therapy


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

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 |
| --- | --- |
| Active Comparator: Treated Group<br>This group will receive actual shockwave treatment | Device: Extracorporeal Shockwave Therapy<br>* Energy Density - 0.02 - 0.15 mJ/mm2<br>* Other names: Vascuspec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF score |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rigid Score (RS) |  | 3 months | 
| Quality of Erection Questionnaire (QEQ) |  | 3 months | 
| Self-Esteem And Relationship Questionnaire (SEAR) |  | 3 months | 
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT) |  | 3 months | 
| Side Effects |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ED, Erectile Dysfunction, Erectile dysfunction treated with PDE-5 inhibitors