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

Zealand University Hospital

Status: Completed

Conditions: Erectile Dysfunction

Treatments: Device: Li-ESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT03006536

SJ-590

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Li-ESWT

Experimental group

Description:

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

Treatment:

Device: Li-ESWT

Sham

Sham Comparator group

Description:

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

Treatment:

Device: Li-ESWT