Phase
Condition
Erectile Dysfunction
Impotence
Infertility
Treatment
Shockwave Therapy (SWT)
Autologous Platelet-Rich Plasma (PRP)
Clinical Study ID
Ages 30-80 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male
Between 30 to 80 years of age (inclusive).
Be able to provide written informed consent.
Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based onInternational Index of Erectile Dysfunction - Erectile Function (IIEF-EF)questionnaire score.
Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history ofHemoglobin A1C > 7% OR on medical therapy for Diabetes.
Be in a stable relationship and have a minimum of 2 sexual attempts per month for atleast one month prior to enrollment.
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, penile fracture, Peyronie's Disease, or penilecurvature that negatively influences sexual activity.
Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).
Psychogenic ED as determined by study investigator.
Patients using Intracavernous Injections (ICI) for management of ED.
Patients with generalized polyneuropathy, neurological conditions, or psychiatricdisease (such as bipolar disorder or depression).
Have a serious comorbid illness or condition 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 5 (PDE5) inhibitorsfor therapy of ED.
Poorly controlled diabetes as indicated by Hemoglobin a1c > 7.5%.
Use of antiplatelet medications
Study Design
Connect with a study center
University of Miami, School of Medicine - Desai Sethi Urology Institute
Miami, Florida 33136
United StatesSite Not Available
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