Phase
Condition
Male Hormonal Deficiencies/abnormalities
Erectile Dysfunction
Impotence
Treatment
Shock Wave therapy (SWT)
Sham SWT
Placebo Saline
Clinical Study ID
Ages 30-80 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be Male
Be 30 to 80 years of age (inclusive).
Be able to provide written informed consent.
Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
Sexually active in a stable, heterosexual relationship of more than three monthsduration.
IIEF-EF score 12-25 at screening
Agree to attempt sexual intercourse at least 4 times per month for the duration ofthe study without being under the influence of alcohol or recreational drugs.
Agree to comply with all study related tests/procedures.
Exclusion
Exclusion Criteria:
Previous penile surgery of any kind (except circumcision and condyloma removal),such as penile lengthening, penile cancer surgery, penile plication, grafting.
Previous history of priapism or penile fracture
Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
Current or previous hormone usage, other than prescribed testosterone, clomiphene orthyroid medication. (Subjects with prior or current use of hormonal treatment forprostate cancer are also excluded.
Psychogenic ED as determined by study investigator.
Anatomical (Peyronie's Disease or penile curvature that negatively influences sexualactivity) or neurological abnormalities in the treatment area.
Patients using Intracavernosal Injection (ICI) for management of ED
Patients with generalized polyneuropathy, or neurological conditions irrespective ofcause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
Have a serious comorbid illness/condition/behavior that, in the opinion of theinvestigator, may compromise the safety or compliance of the subject or precludesuccessful completion of the study.
History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5)inhibitors for therapy of ED.
Any history of significant psychiatric disease, such as bipolar disorder orpsychosis, greater than one lifetime episode of major depression, current depressionof moderate or greater severity. Patients who are currently using SelectiveSerotonin Reuptake Inhibitors (SSRI) or psychotropic medications.
Hemoglobin a1c >9%.
Study Design
Connect with a study center
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
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