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

Erectile Dysfunction Clinical Trial

— ESWTvsED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063061
• Other study ID #: CIV-13-07-011546
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: December 23, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Denmark	Hospital of Southern Denmark	Sonderborg	Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
Grzegorz Fojecki	Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013 Apr;5(2):95-9. doi: 10.1177/1756287212470696. — View Citation

Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6 — View Citation

Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome	Assesed after complition af clinical trial	18 weeks	No
Other	Number of Participants with Adverse Events	During treatment period all patients will be examined for advers events	18 weeks	Yes
Primary	International Index of Erectile Function (IIEF) outcome increases by 5 points		1 year	No
Secondary	Erectile Hardness Scale (EHS) outcome is equal or higher than 3.		1 year	No

External Links

•   regional ethical committee
•   University of Southern Denmark