Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
This trial has been completed.
|Treatments||sham treatment, eswt treatment|
|Collaborator||University of Southern Denmark|
|Start date||February 2014|
|End date||August 2014|
|Trial size||126 participants|
|Trial identifier||NCT02063061, CIV-13-07-011546|
The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
International Index of Erectile Function (IIEF) outcome increases by 5 points
time frame: 1 year
Erectile Hardness Scale (EHS) outcome is equal or higher than 3.
time frame: 1 year
Male participants at least 40 years old.
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
|Official title||Low-energy Linear Extracorporal Shock Wave Therapy 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.|
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