Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders

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. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

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


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 |
| --- | --- |
| Sham Comparator: shock wave treatment<br> | Device: MEDISPEC treatment probe<br>* shock wave treatment<br>* Other names: Omnispec model ED1000;|
| Sham Comparator: MEDISPEC Sham<br>MEDISPEC Probe does not deliver energy but creates same noise and sensation of active probe | Device: MEDISPEC treatment probe<br>* shock wave treatment<br>* Other names: Omnispec model ED1000;|

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