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

NCT01262157 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-05-19

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 that do not respond to oral therapy (PDE-5 inhibitors).

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Yoram Vardi, prof · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-12-31
Completion
2012-01-31

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 NCT01262157 on ClinicalTrials.gov