The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i

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 LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

Detailed Description
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We included severe ED patients that underwent radical prostatectomy at least one year previously and 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. This study further emphasises the need to study specific populations with unique etiologies causing ED.

Official Title
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The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy 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: Post Radical prostatectomy 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 after first visit | 

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