Pilot Study of the Treatment of Erectile Dysfunction (ED) With Extracorporeal Shockwave Therapy (ESWT)

Storz Medical

Status and phase: Terminated; Phase 3

Conditions: Erectile Dysfunction

Treatments: Device: shock waves

Study type: Interventional

Funder types: Industry

Identifiers

NCT02068417

STU10/002

Details and patient eligibility

About

The objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.The aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Erectile dysfunction for more than 6 months
• Informed consent
• Positive effect of phosphodiesterase type 5 inhibitor (PDE5i)
• IIEF-15 score less than 20
• No neurological disease
• Stable partnership for more than 3 months
• Age 18-75

Exclusion criteria

• Total prostatectomy
• Another reason for ED except for vascular disorder
• Clinically significant hematological disease
• Heart stroke, Arrythmia during the last 6 months
• Cancer during the last 5 years
• Intake of antiandrogen
• ED treatment with the last 7 days
• IIEF score higher than, equal to 20
• Previous shockwave treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Shock wave treatment

Active Comparator group

Description:

Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)

Treatment:

Device: shock waves

Placebo Shock wave treatment

Placebo Comparator group

Description:

Shock waves are prohibited to enter the body by placebo stand-off.

Treatment:

Device: shock waves