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

March 5, 2015 updated by: Storz Medical AG

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Chemnitz, Germany
        • Bethanien Krankenhaus Chemnitz gemeinnützige GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Shock wave treatment
Shock waves are applied extracorporeally with 0.1 millijoule per square millimeter (mJ/mm2)
Device: shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Other Names:
  • ESWT
  • extracorporeal shock wave therapy
Placebo Comparator: Placebo Shock wave treatment
Shock waves are prohibited to enter the body by placebo stand-off.
Device: shock waves
extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
Other Names:
  • ESWT
  • extracorporeal shock wave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of erection problems on the sex life (International Index of Erectile Function (IIEF) Questionnaire)
Time Frame: up to 6 months post treatment
up to 6 months post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of erection (Quality of Erection Questionnaire)
Time Frame: At screening, 1, 3 and 6 months post treatment
At screening, 1, 3 and 6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Storz Medical AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU10/002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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