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Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

This study has been completed.
Rambam Health Care Campus
Information provided by:
Medispec Identifier:
First received: May 12, 2009
Last updated: January 23, 2011
Last verified: November 2010

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.

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

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
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Please refer to this study by its identifier: NCT00901056

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

Responsible Party: Prof. Yoram Vardi, Rambam Medical Center Identifier: NCT00901056     History of Changes
Other Study ID Numbers: ED-ESWT
Study First Received: May 12, 2009
Last Updated: January 23, 2011

Keywords provided by Medispec:
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 processed this record on August 18, 2017