The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders

Study Overview
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Brief Summary
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Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.

Detailed Description
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We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.

Official Title
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The Effect of Low Intensity Shock Wave Therapy in Severe ED Patients Not Responding to Oral Medication

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: LI-ESWT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ED of more than 6 months Rigidity score ≤ 2 during PDE5i therapy Stable heterosexual relationship for more than 3 months Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 . Exclusion Criteria: Prior surgery or radiotherapy in pelvic region Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities Clinically significant chronic hematological disease Anti-androgens, oral or injectable androgens Cardiovascular conditions that prevent sexual activity

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LI-ESWT<br>Low intensity shock wave treatment- 12 sessions | Device: LI-ESWT<br>* Low intensity shock wave treatment - 12 sessions<br>* Other names: Omnispec model ED1000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-ED Domain score | Change of 5 points and above in IIEF-ED Domain score | 17 weeks after first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rigidity scale | a change to 3 or 4 points in the rigidty scale | 17 weeks from visit 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LI-ESWT, Erectile Dysfunction, Non PDE5 inhibitor responders, Shock wave