Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial

Study Overview
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Brief Summary
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The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).

Official Title
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Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial

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: Age 18-70 years A history of erectile dysfunction for >6 months IIEF-ED score < 25 In a stable heterosexual relationship for at least 6 months Willingness to attempt sexual intercourse at least twice per week during the study and follow-up Exclusion Criteria: Psychogenic ED as assessed by a standardized interview (attachment 2) Known psychiatric illness Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord injury, and a history of stroke) Traumatic nerve injury Previous pelvic surgery or radiation Heart disease in the form of unstable angina, NYHA class >II heart failure, uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease Endocrine disease including hypogonadism (total testosterone <12 nmol/l) Insulin dependent or uncontrolled diabetes mellitus Dependence on erectogenic aids other than PDE5-Inhibitors Use of medications which have been shown to interfere with erections Use of anticoagulant medications other than low dose aspirin Active cancer A diagnoses of Peyronie's disease and/or prior occurrence of priapism Alcohol abuse (more than 21 containers of alcohol per week)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: Li-ESWT<br>Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions | Device: Li-ESWT<br>* Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions<br>|
| Sham Comparator: Sham<br>Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions | Device: Li-ESWT<br>* Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function (IIEF) |  | 1 months |