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Clinical Trials/NCT02063061
NCT02063061
Completed
Not Applicable

Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.

Grzegorz Fojecki1 site in 1 country126 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erectile Dysfunction
Sponsor
Grzegorz Fojecki
Enrollment
126
Locations
1
Primary Endpoint
International Index of Erectile Function (IIEF) outcome increases by 5 points
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.

Detailed Description

Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Grzegorz Fojecki
Responsible Party
Sponsor Investigator
Principal Investigator

Grzegorz Fojecki

MD

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • Erectile dysfunction for at least 6 months
  • In relationships
  • Patient accept not to use any other therapy against erectile dysfunction

Exclusion Criteria

  • Prostatectomy
  • Radiotherapy in pelvis
  • Hormonal therapy against prostate cancer
  • Anatomical penis disorder
  • Penile prosthesis
  • Treatment with anticoagulants (except acetylsalicylic acid 75 mg)
  • Psychiatric disorder
  • Hypogonadism
  • IIEF score higher than 25
  • Pregnant partner og delivered within last 12 months

Outcomes

Primary Outcomes

International Index of Erectile Function (IIEF) outcome increases by 5 points

Time Frame: 1 year

Secondary Outcomes

  • Erectile Hardness Scale (EHS) outcome is equal or higher than 3.(1 year)

Study Sites (1)

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