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Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders (LI-ESWT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01274923
Recruitment Status : Unknown
Verified January 2011 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : January 12, 2011
Last Update Posted : May 18, 2011
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 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. On screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. A one-month active treatment with PDE5i will be provided followed by re-evaluation using the same questionnaires. Then another one-month period without PDE5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the Flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the Penis will be performed. At the end of this screening pahse the first shock wave session will be performed. Altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. Follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sham Comparator: shock wave treatment Device: "MEDISPEC" treatment probe
shock wave treatment
Other Name: Omnispec model ED1000

Sham Comparator: "MEDISPEC" Sham
"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
Device: "MEDISPEC" treatment probe
shock wave treatment
Other Name: Omnispec model ED1000

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01274923

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Contact: Ilan Gruenwald, MD 00972544474341
Contact: Yoram Gruenwald, Prof 0097248542819

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Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Ilan Gruenwald, MD    00972544474341   
Principal Investigator: Yoram Vardi, Prof.         
Sub-Investigator: Ilan Gruenwald, MD         
Sub-Investigator: Boaz Appel, MD         
Sub-Investigator: Ezra Gerber, RN         
Sub-Investigator: Omar Massarwa, RN         
Sub-Investigator: Yaron Ofer, MD         
Sponsors and Collaborators
Rambam Health Care Campus
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Responsible Party: Prof Yoram Vardi, Rambam Healthcare Campus Identifier: NCT01274923    
Other Study ID Numbers: 0200-09-rmb europe
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: January 2011
Keywords provided by Rambam Health Care Campus:
Erectile dysfunction
Low Intensity Shock Wave
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders