Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study (LI-ESWT)

May 18, 2011 updated by: Rambam Health Care Campus

A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy

Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

Study Type

Interventional

Enrollment (Anticipated)

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
        • Recruiting
        • Rambam Medical Center
        • Sub-Investigator:
          • Boaz Appel, MD
        • Sub-Investigator:
          • Ilan Gruenwald, MD
        • Contact:

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 85 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 during PDE5i therapy
  • SHIM <21 during 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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: placebo
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Other Names:
  • Extracorporeal Shockwave Therapy
  • Low intensity shock wave Therapy
Active Comparator: Shock wave therapy
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
Device: Low intensity shock wave therapy
Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Other Names:
  • Low Intensity Extra Corporal Shock Wave Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IIEF-ED Domain
Time Frame: 17 weeks
A change of 5 points or more will indicate success
17 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rigidity score
Time Frame: 17 weeks
a scale of 3 and above indicates success
17 weeks

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yoram Vardi, prof, Rambam Health Care Campus

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

April 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

July 11, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 507-10 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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