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Completed

NCT Number: NCT02063061

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

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

Completed

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of Southern Denmark

Sønderborg, Southern Denmark, 6400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Critical health disease
  • Neurological disorders

Treatment and study plan

Sham treatment

Device

Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.

Other names: Sham

ESWT treatment

Device

ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.

Other names: ESWT

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Other outcomes

  1. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome

    Time frame: 18 weeks

    Assesed after complition af clinical trial

  2. Number of Participants with Adverse Events

    Time frame: 18 weeks

    During treatment period all patients will be examined for advers events

Sponsors and collaborators

Lead sponsor

Grzegorz Fojecki

Other

Collaborators

  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Acronym: ESWTvsED

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 14, 2014
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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