Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.

Study Overview
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Brief Summary
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The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.

Detailed Description
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Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.

Official Title
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Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Sham treatment
* Device: ESWT treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erectile dysfunction for at least 6 months In relationships Patient accept not to use any other therapy against erectile dysfunction Exclusion Criteria: Prostatectomy Radiotherapy in pelvis Hormonal therapy against prostate cancer Anatomical penis disorder Penile prosthesis Treatment with anticoagulants (except acetylsalicylic acid 75 mg) Psychiatric disorder Hypogonadism IIEF score higher than 25 Pregnant partner og delivered within last 12 months Critical health disease Neurological disorders

Ages Eligible for Study
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Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham treatment<br>Subject will answer standardized questionnaires. Sham treatment arm will receive initially 5 sham series and after they answer standardized questionnaires they will receive 5 series of active treatment. Afterwards patients will answer standardized questionnaires again. | Device: Sham treatment<br>* Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.<br>* Other names: Sham;Device: ESWT treatment<br>* ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.<br>* Other names: ESWT;|
| Active Comparator: ESWT treatment<br>Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again. | Device: ESWT treatment<br>* ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.<br>* Other names: ESWT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function (IIEF) outcome increases by 5 points |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Hardness Scale (EHS) outcome is equal or higher than 3. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal shock wave therapy ESWT, erectile dysfunction