Erectile Dysfunction
Conditions
Keywords
extracorporeal shock wave therapy ESWT, 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.
Interventions
DEVICESham 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.
DEVICEESWT treatment
ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
Sponsors
University of Southern Denmark
Region of Southern Denmark
Grzegorz Fojecki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index of Erectile Function (IIEF) outcome increases by 5 points | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Erectile Hardness Scale (EHS) outcome is equal or higher than 3. | 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome | 18 weeks | Assesed after complition af clinical trial |
| Number of Participants with Adverse Events | 18 weeks | During treatment period all patients will be examined for advers events |
Countries
Denmark
Outcome results
None listed