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

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ClinicalTrials.gov Identifier: NCT01274156
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : January 11, 2011
Sponsor:
Collaborator:
Medispec
Information provided by:
Rambam Health Care Campus

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
Erectile Dysfunction 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 Type : Interventional  (Clinical Trial)
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 : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: shock wave treatment Device: "MEDISPEC" treatment probe
300 shocks in 5 different anatomical locations of the penis.
Other Name: 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 Name: 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 Name: VASCUSPEC
Device: Sham
Probe does not deliver energy but creates same noise and sensation of active probe
Other Name: Vasculospec



Primary Outcome Measures :
  1. International Index of Erectile function- Erectile Function Domain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274156


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Medispec

Responsible Party: Prof Yoram Vardi, Rambam Healthcare Campus
ClinicalTrials.gov Identifier: NCT01274156     History of Changes
Other Study ID Numbers: 3060 RMB
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Keywords provided by Rambam Health Care Campus:
Erectile dysfunction
Low Intensity Shock Wave

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