Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy

Study Overview
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Brief Summary
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Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.

Detailed Description
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All patients have undergone prostatectomy and are without recurrence. None of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy). Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score). Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2. Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment. For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.

Official Title
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Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy

Conditions
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Erectile Function

Intervention / Treatment
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* Procedure: Extracorporeal Shockwave Terapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erectil dysfunction after radical prostatectomy less than two years ago IIEF - less than 20 EHS - less than 4 Exclusion Criteria: drop out not sexual active penile prostesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: Randomization to active or placebo treatment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESWT<br>500 shockwave 3 different points on penis bilateral | Procedure: Extracorporeal Shockwave Terapy<br>* Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter<br>* Other names: ESWT;|
| Placebo Comparator: Placebo<br>500 shockwave 3 different points on penis bilateral | Procedure: Extracorporeal Shockwave Terapy<br>* Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter<br>* Other names: ESWT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-5 point | Change in IIEF-5 point | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Function, Prostatectomy, Extracorporeal Shock Wave Therapy, IIEF-5