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Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

Sponsor
Medispec (Industry)
Overall Status
Completed
CT.gov ID
NCT00901056
Collaborator
Rambam Health Care Campus (Other)
20
Enrollment
1
Location
1
Arm
15.9
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Extracorporeal Shockwave Therapy
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
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
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IIEF score [3 months]

    Secondary Outcome Measures

    1. Rigid Score (RS) [3 months]

    2. Quality of Erection Questionnaire (QEQ) [3 months]

    3. Self-Esteem And Relationship Questionnaire (SEAR) [3 months]

    4. Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT) [3 months]

    5. Side Effects [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Medical Center Haifa Israel

    Sponsors and Collaborators

    • Medispec
    • Rambam Health Care Campus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00901056
    Other Study ID Numbers:
    • ED-ESWT
    First Posted:
    May 13, 2009
    Last Update Posted:
    Jan 25, 2011
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    ED
    Erectile Dysfunction
    Erectile dysfunction treated with PDE-5 inhibitors
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Jan 25, 2011