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

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ClinicalTrials.gov Identifier: NCT02063061
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : December 28, 2016
Sponsor:
Collaborators:
University of Southern Denmark
Region of Southern Denmark
Information provided by (Responsible Party):
Grzegorz Fojecki, University of Southern Denmark

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Sham treatment Device: ESWT treatment Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham treatment
Subject will answer standardized questionnaires. Sham treatment arm will receive initially 5 sham series and after they answer standardized questionnaires they will receive 5 series of active treatment. Afterwards patients will answer standardized questionnaires again.
 Device: Sham treatment
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 Name: Sham

Device: ESWT treatment
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Other Name: ESWT
Active Comparator: ESWT treatment
Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.
 Device: ESWT treatment
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Other Name: ESWT


Outcome Measures
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Primary Outcome Measures :
  1. International Index of Erectile Function (IIEF) outcome increases by 5 points [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Erectile Hardness Scale (EHS) outcome is equal or higher than 3. [ Time Frame: 1 year ]

Other Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • Critical health disease
  • Neurological disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063061


Locations
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Denmark
Hospital of Southern Denmark
Sonderborg, Southern Denmark, Denmark, 6400
Sponsors and Collaborators
Grzegorz Fojecki
University of Southern Denmark
Region of Southern Denmark
Investigators
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Study Director: Palle Oshter, professor University of Southern Denmark
More Information
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Additional Information:
regional ethical committee  This link exits the ClinicalTrials.gov site University of Southern Denmark  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Grzegorz Fojecki, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02063061     History of Changes
Other Study ID Numbers: CIV-13-07-011546
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Grzegorz Fojecki, University of Southern Denmark:
extracorporeal shock wave therapy ESWT
erectile dysfunction

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders