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Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901056
First Posted: May 13, 2009
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rambam Health Care Campus
Information provided by:
Medispec
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction Device: Extracorporeal Shockwave Therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin

Resource links provided by NLM:


Further study details as provided by Medispec:

Primary Outcome Measures:
  • IIEF score [ Time Frame: 3 months ]

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

Enrollment: 20
Study Start Date: November 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treated Group
This group will receive actual shockwave treatment
Device: Extracorporeal Shockwave Therapy
Energy Density - 0.02 - 0.15 mJ/mm2
Other Name: Vascuspec

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901056


Locations
Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Medispec
Rambam Health Care Campus
Investigators
Principal Investigator: Yoram Vardi, Professor Rambam Health Care Campus
  More Information

Responsible Party: Prof. Yoram Vardi, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00901056     History of Changes
Other Study ID Numbers: ED-ESWT
First Submitted: May 12, 2009
First Posted: May 13, 2009
Last Update Posted: January 25, 2011
Last Verified: November 2010

Keywords provided by Medispec:
ED
Erectile Dysfunction
Erectile dysfunction treated with PDE-5 inhibitors

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders