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LI-ESWT: Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT01274156
Collaborator
Medispec (Industry)
60
Enrollment
1
Location
2
Arms
3
Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.

Condition or Disease Intervention/Treatment Phase
  • Device: "MEDISPEC" treatment probe
  • Device: "MEDISPEC" Sham Probe
  • Device: "MEDISPEC" Low intensity shock waves
  • Device: Sham
 Phase 3

Detailed Description

This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: shock wave treatment

Device: "MEDISPEC" treatment probe
300 shocks in 5 different anatomical locations of the penis.
Other Names:
  • VASCUSPEC

    • Device: "MEDISPEC" Low intensity shock waves
    Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min
    Other Names:
  • VASCULOSPEC

    		•
    Sham Comparator: "MEDISPEC" Sham

    "MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe

    Device: "MEDISPEC" Sham Probe
    Sham probe applied same as treatment probe without energy
    Other Names:
  • VASCUSPEC

    • Device: Sham
    Probe does not deliver energy but creates same noise and sensation of active probe
    Other Names:
  • Vasculospec

    		•

    Outcome Measures

    Primary Outcome Measures

    1. International Index of Erectile function- Erectile Function Domain [At screening and 17 weeks later at last visit]

      An increase in score of 5points and above will be considered success.

    Secondary Outcome Measures

    1. Rigidity scale [At screening and 17 weeks later at last visit]

      A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success

    2. Flow Mediated Dilatation Technique [At screening and 17 weeks later at last visit]

      A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ED of more than 6 months

    • Rigidity score ≥ 3 under PDE5i therapy

    • SHIM ≤21 under 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 Health Care Campus Haifa Israel 31096

    Sponsors and Collaborators

    • Rambam Health Care Campus
    • Medispec

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01274156
    Other Study ID Numbers:
    • 3060 RMB
    First Posted:
    Jan 11, 2011
    Last Update Posted:
    Jan 11, 2011
    Last Verified:
    Jan 1, 2011
    Keywords provided by , ,
    Erectile dysfunction
    Low Intensity Shock Wave
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Jan 11, 2011