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Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction

NCT01274156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-01-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

"MEDISPEC" treatment probe

300 shocks in 5 different anatomical locations of the penis.

DEVICE

"MEDISPEC" Sham Probe

Sham probe applied same as treatment probe without energy

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

DEVICE

Sham

Probe does not deliver energy but creates same noise and sensation of active probe

Sponsors & Collaborators

  • Medispec

    collaborator INDUSTRY

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

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 NCT01274156 on ClinicalTrials.gov