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NCT02068417 Clinical Trial

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
Secondary ID
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

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
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