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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

Tracking Information
First Submitted Date  ICMJE January 9, 2014
First Posted Date  ICMJE February 14, 2014
Last Update Posted Date December 28, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
International Index of Erectile Function (IIEF) outcome increases by 5 points [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02063061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
Erectile Hardness Scale (EHS) outcome is equal or higher than 3. [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 12, 2014)
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome [ Time Frame: 18 weeks ]
    Assesed after complition af clinical trial
  • Number of Participants with Adverse Events [ Time Frame: 18 weeks ]
    During treatment period all patients will be examined for advers events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
Official Title  ICMJE Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Sham treatment
    • Device: ESWT treatment
  • Active Comparator: ESWT treatment
    Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.
    Intervention: Device: ESWT treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2014)
126
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02063061
Other Study ID Numbers  ICMJE CIV-13-07-011546
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Grzegorz Fojecki, University of Southern Denmark
Study Sponsor  ICMJE Grzegorz Fojecki
Collaborators  ICMJE
  • University of Southern Denmark
  • Region of Southern Denmark
Investigators  ICMJE
Study Director: Palle Oshter, professor University of Southern Denmark
PRS Account University of Southern Denmark
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP