Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

January 23, 2011 updated by: Medispec

Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

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

  • Israel
      • Haifa, Israel
        • Rambam Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • ED of more than 6 months
  • At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
  • Positive response to PDE-5 inhibitors
  • IIEF-5 domain score of 12-20 denoting mild to severe ED
  • Non-Neurological pathology
  • Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • NPT - normal/flat
  • Prior prostatectomy surgery
  • Any cause of ED other than vascular related
  • Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Cardiovascular conditions that prevent sexual activity
  • History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
  • Cancer within the past 5 years.
  • Anti-androgens, oral or injectable androgens
  • Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treated Group
This group will receive actual shockwave treatment
Device: Extracorporeal Shockwave Therapy
Energy Density - 0.02 - 0.15 mJ/mm2
Other Names:
  • Vascuspec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IIEF score
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side Effects
Time Frame: 3 months
3 months
Rigid Score (RS)
Time Frame: 3 months
3 months
Quality of Erection Questionnaire (QEQ)
Time Frame: 3 months
3 months
Self-Esteem And Relationship Questionnaire (SEAR)
Time Frame: 3 months
3 months
Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Medispec

Collaborators

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yoram Vardi, Professor, Rambam Health Care Campus

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

November 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 23, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED-ESWT

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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