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LI-ESWT: Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Unknown status
CT.gov ID
NCT01262157
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
21
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Condition or Disease Intervention/Treatment Phase
  • Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
  • Device: Low intensity shock wave therapy
 Phase 3

Detailed Description

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy
Study Start Date :
Apr 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: placebo

We use the same probe that induces the same sensation on the penis and the same noise yet no energy

Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
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.
Other Names:
  • Low intensity shock wave Therapy
  • Extracorporeal Shockwave Therapy

    		•
    Active Comparator: Shock wave therapy

    12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment

    Device: Low intensity shock wave therapy
    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.
    Other Names:
  • Low Intensity Extra Corporal Shock Wave Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IIEF-ED Domain [17 weeks]

      A change of 5 points or more will indicate success

    Secondary Outcome Measures

    1. rigidity score [17 weeks]

      a scale of 3 and above indicates success

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ED of more than 6 months

    • Rigidity score < 3 during PDE5i therapy

    • SHIM <21 during PDE5i therapy

    • Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

    Exclusion Criteria:

    • Prior prostatectomy surgery

    • Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities

    • Clinically significant chronic hematological disease

    • Anti-androgens, oral or injectable androgens

    • Radiotherapy in pelvic region

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Medical Center Haifa Israel 31096

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01262157
    Other Study ID Numbers:
    • 507-10 RMB
    First Posted:
    Dec 17, 2010
    Last Update Posted:
    May 19, 2011
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    Erectile dysfunction
    PDE5 Inhibitor
    Low intensity shock wave therapy.
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of May 19, 2011