Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study

Study Overview
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Brief Summary
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Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Detailed Description
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In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Official Title
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A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
* Device: Low intensity shock wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ED of more than 6 months Rigidity score < 3 during PDE5i therapy SHIM <21 during PDE5i therapy Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months Exclusion Criteria: Prior prostatectomy surgery Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities Clinically significant chronic hematological disease Anti-androgens, oral or injectable androgens Radiotherapy in pelvic region

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: placebo<br>We use the same probe that induces the same sensation on the penis and the same noise yet no energy | Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)<br>* 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.<br>* Other names: Extracorporeal Shockwave Therapy;|
| Active Comparator: Shock wave therapy<br>12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment | Device: Low intensity shock wave therapy<br>* 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.<br>* Other names: Low Intensity Extra Corporal Shock Wave Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-ED Domain | A change of 5 points or more will indicate success | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rigidity score | a scale of 3 and above indicates success | 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, PDE5 Inhibitor, Low intensity shock wave therapy.