Erectile Dysfunction
Conditions
Brief summary
The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function and triggers angiogenesis through induction of local growth factors and endothelial nitric oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies investigating the clinical effects have been encouraging. Meanwhile, randomized trials have shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed statistically greater improvements in the Erectile Function Domain of the International Index of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment (p=0.032).
Interventions
DEVICELi-ESWT
Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-70 years * A history of erectile dysfunction for \>6 months * IIEF-ED score \< 25 * In a stable heterosexual relationship for at least 6 months * Willingness to attempt sexual intercourse at least twice per week during the study and follow-up
Exclusion criteria
* Psychogenic ED as assessed by a standardized interview (attachment 2) * Known psychiatric illness * Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord injury, and a history of stroke) * Traumatic nerve injury * Previous pelvic surgery or radiation * Heart disease in the form of unstable angina, NYHA class \>II heart failure, uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease * Endocrine disease including hypogonadism (total testosterone \<12 nmol/l) * Insulin dependent or uncontrolled diabetes mellitus * Dependence on erectogenic aids other than PDE5-Inhibitors * Use of medications which have been shown to interfere with erections * Use of anticoagulant medications other than low dose aspirin * Active cancer * A diagnoses of Peyronie's disease and/or prior occurrence of priapism * Alcohol abuse (more than 21 containers of alcohol per week)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index of Erectile Function (IIEF) | 1 months |
Countries
Denmark
Outcome results
None listed