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

Phase 3TerminatedNCT02068417

Storz Medical AG40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Erectile Dysfunction

Interventions

shock wavesDEVICE

extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Bethanien Krankenhaus Chemnitz gemeinnützige GmbH

Chemnitz, Germany

Outcomes

Primary Outcomes

Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)

Time frame: up to 6 months post treatment

Secondary Outcomes

Quality of erection (Quality of Erection Questionnaire)

Time frame: At screening, 1, 3 and 6 months post treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.