Erectile Dysfunction Clinical Trial
— ESWTvsEDOfficial title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Hospital of Southern Denmark | Sonderborg | Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Grzegorz Fojecki | Region of Southern Denmark, University of Southern Denmark |
Denmark,
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
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 |
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