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Low Intensity Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction- 4 Arms

NCT01442077 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-01-18

No results posted yet for this study

Summary

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 who respond to oral therapy (PDE-5 inhibitors). The current study will check 4 different arm.

Conditions

Interventions

DEVICE

Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).

DEVICE

Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.

DEVICE

Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).

DEVICE

Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)

Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Yoram Vardi, Prof. · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442077 on ClinicalTrials.gov