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

Erectile Dysfunction Clinical Trial

Official title:

A Prospective, Randomised, Blinded, Placebo-controlled Pilot Study of the Treatment of Erectile Dysfunction With Extracorporeal Shockwave Therapy (ESWT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02068417
• Other study ID #: STU10/002
• Status: Terminated
• Phase: Phase 3
• First received: February 19, 2014
• Last updated: March 5, 2015
• Start date: October 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Storz Medical AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareGermany: Federal Institute for Drugs and Medical DevicesPakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Germany	Bethanien Krankenhaus Chemnitz gemeinnützige GmbH	Chemnitz

Sponsors (1)

Lead Sponsor	Collaborator
Storz Medical AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)		up to 6 months post treatment	No
Secondary	Quality of erection (Quality of Erection Questionnaire)		At screening, 1, 3 and 6 months post treatment	No