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Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Unknown status
CT.gov ID
NCT01317693
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
33.1
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.

Condition or Disease Intervention/Treatment Phase
  • Device: Low intensity shock waves
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment LI-ESWT

Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.

Device: Low intensity shock waves
1500 shocks, Energy Density - 0.09 mJ/mm2
Other Names:
  • Omnispec model ED1000

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success [13 weeks]

    Secondary Outcome Measures

    1. Rigidity Score Questionaire- an increase by at least 1 point is considered success [13 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    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

    • Rambam Health Care Campus

    Investigators

    • Principal Investigator: Ilan Gruenwald, MD, Rambam Health Care Campus
    • Study Director: Yoram Vardi, Prof., Rambam Health Care Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    i_gruenwald, MD, Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT01317693
    Other Study ID Numbers:
    • 0571-10-RMB
    First Posted:
    Mar 17, 2011
    Last Update Posted:
    Dec 19, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by i_gruenwald, MD, Rambam Health Care Campus
    LI-ESWT
    Erectile Dysfunction
    ED
    Shock waves
    Therapy
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Dec 19, 2012