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

January 10, 2011 updated by: Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At screening and 17 weeks later at last visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At screening and 17 weeks later at last visit
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.
At screening and 17 weeks later at last visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Medispec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3060 RMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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