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
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, see Learn About Clinical Studies.

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 July 20, 2014