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Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Rambam Health Care Campus
Information provided by:
Medispec
ClinicalTrials.gov Identifier:
NCT00901056
First received: May 12, 2009
Last updated: January 23, 2011
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rigid Score (RS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of Erection Questionnaire (QEQ) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Self-Esteem And Relationship Questionnaire (SEAR) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on November 24, 2014