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

This study has been completed.
Sponsor:
Collaborator:
Medispec
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01274156
First received: December 14, 2010
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Erectile Dysfunction
Device: "MEDISPEC" treatment probe
Device: "MEDISPEC" Sham Probe
Device: "MEDISPEC" Low intensity shock waves
Device: Sham
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • International Index of Erectile function- Erectile Function Domain [ Time Frame: At screening and 17 weeks later at last visit ] [ Designated as safety issue: No ]
    An increase in score of 5points and above will be considered success.


Secondary Outcome Measures:
  • Rigidity scale [ Time Frame: At screening and 17 weeks later at last visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274156

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

No publications provided

Responsible Party: Prof Yoram Vardi, Rambam Healthcare Campus
ClinicalTrials.gov Identifier: NCT01274156     History of Changes
Other Study ID Numbers: 3060 RMB
Study First Received: December 14, 2010
Last Updated: January 10, 2011
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Shock
Erectile Dysfunction
Pathologic Processes
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014