Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction

Study Overview
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Brief Summary
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This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Detailed Description
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This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.

Official Title
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The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: MEDISPEC treatment probe
* Device: MEDISPEC Sham Probe
* Device: MEDISPEC Low intensity shock waves
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ED of more than 6 months Rigidity score ≥ 3 under PDE5i therapy SHIM ≤21 under 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: 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: shock wave treatment<br> | Device: MEDISPEC treatment probe<br>* 300 shocks in 5 different anatomical locations of the penis.<br>* Other names: VASCUSPEC;Device: MEDISPEC Low intensity shock waves<br>* Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min<br>* Other names: VASCULOSPEC;|
| Sham Comparator: MEDISPEC Sham<br>MEDISPEC Probe does not deliver energy but creates same noise and sensation of active probe | Device: MEDISPEC Sham Probe<br>* Sham probe applied same as treatment probe without energy<br>* Other names: VASCUSPEC;Device: Sham<br>* Probe does not deliver energy but creates same noise and sensation of active probe<br>* Other names: Vasculospec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile function- Erectile Function Domain | An increase in score of 5points and above will be considered success. | At screening and 17 weeks later at last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rigidity scale | A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success | At screening and 17 weeks later at last visit | 
| Flow Mediated Dilatation Technique | A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success. | At screening and 17 weeks later at last visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction, Low Intensity Shock Wave