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

Phase 3

Terminated

• Conditions: Erectile Dysfunction
• Interventions: Device: shock waves

• Registration Number: NCT02068417
• Lead Sponsor: Storz Medical AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-21
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Shock wave treatment	shock waves	Shock waves are prohibited to enter the body by placebo stand-off.
Shock wave treatment	shock waves	Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)

Primary Outcome Measures

Name	Time	Method
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)	up to 6 months post treatment

Secondary Outcome Measures

Name	Time	Method
Quality of erection (Quality of Erection Questionnaire)	At screening, 1, 3 and 6 months post treatment

Trial Locations

Locations (1)

Bethanien Krankenhaus Chemnitz gemeinnützige GmbH; 🇩🇪 Chemnitz, Germany