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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Southern Denmark
Sponsor:
Collaborators:
University of Southern Denmark
Region Southern Denmark
Information provided by (Responsible Party):
Grzegorz Fojecki, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT02063061
First received: January 9, 2014
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Erectile Dysfunction
Device: Sham treatment
Device: ESWT treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • International Index of Erectile Function (IIEF) outcome increases by 5 points [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erectile Hardness Scale (EHS) outcome is equal or higher than 3. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    Assesed after complition af clinical trial

  • Number of Participants with Adverse Events [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
    During treatment period all patients will be examined for advers events


Estimated Enrollment: 126
Study Start Date: February 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063061

Contacts
Contact: Palle Osther, professor +4576237347 majbritt.kure.toendering@slb.regionsyddanmark.dk

Locations
Denmark
Hospital of Southern Denmark Recruiting
Sonderborg, Southern Denmark, Denmark, 6400
Contact: Grzegorz Fojecki, MD    +4574183125    grzegorz.lukasz.fojecki@rsyd.dk   
Principal Investigator: Grzegorz Fojecki, MD         
Sponsors and Collaborators
Grzegorz Fojecki
University of Southern Denmark
Region Southern Denmark
Investigators
Study Director: Palle Oshter, professor University of Southern Denmark
  More Information

Additional Information:
Publications:
Responsible Party: Grzegorz Fojecki, MD, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02063061     History of Changes
Other Study ID Numbers: CIV-13-07-011546
Study First Received: January 9, 2014
Last Updated: February 12, 2014
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 19, 2014