Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT02063061
- Lead Sponsor
- Grzegorz Fojecki
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 126
- Erectile dysfunction for at least 6 months
- In relationships
- Patient accept not to use any other therapy against erectile dysfunction
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method International Index of Erectile Function (IIEF) outcome increases by 5 points 1 year
- Secondary Outcome Measures
Name Time Method Erectile Hardness Scale (EHS) outcome is equal or higher than 3. 1 year
Related Research Topics
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Trial Locations
- Locations (1)
Hospital of Southern Denmark
🇩🇰Sonderborg, Southern Denmark, Denmark
Hospital of Southern Denmark🇩🇰Sonderborg, Southern Denmark, Denmark