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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274923
First Posted: January 12, 2011
Last Update Posted: May 18, 2011
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.
Collaborator:
Medispec
Information provided by:
Rambam Health Care Campus
January 9, 2011
January 12, 2011
May 18, 2011
August 2010
August 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01274923 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Same as current
Not Provided
Not Provided
 
Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction in PDE5i Responders
The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's
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.
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Erectile Dysfunction
Device: "MEDISPEC" treatment probe
shock wave treatment
Other Name: Omnispec model ED1000
  • Sham Comparator: shock wave treatment
    Intervention: Device: "MEDISPEC" treatment probe
  • Sham Comparator: "MEDISPEC" Sham
    "MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe
    Intervention: Device: "MEDISPEC" treatment probe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
October 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01274923
0200-09-rmb europe
No
Not Provided
Not Provided
Prof Yoram Vardi, Rambam Healthcare Campus
Rambam Health Care Campus
Medispec
Not Provided
Rambam Health Care Campus
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP