Low-intensity Shockwaves Therapy + Tadalafil 5mg for the Treatment of Severe Erectile Dysfunction

Inclusion Criteria:

1. Consent to participate.
2. Age 40-70 years.
3. Sexually active in a stable, heterosexual relationship of more than three monthsduration.
4. Presence of Erectile Dysfunction for at least 6 months.
5. At screening, diagnosed as Vasculogenic erectile dysfunction based on sexual history.
6. Partial response to highest dose of PDE5i
7. Agree to suspend all other ED therapies, except the assigned study treatments, for theduration of the study.
8. Agree to attempt sexual intercourse and document the outcome using the SexualEncounter Profile (SEP) at least 4 times for the last 4 weeks prior to Visit 2/Randomization, 1 month Follow Up, 3 month Follow Up and 4 month Follow Up withoutbeing under the influence of alcohol or recreational drugs. Agree to document theoutcome using the Sexual Encounter Profile (SEP) diary.
9. IIEF-ED score 1-10 at Visit 2 (after PDE5i washout)
10. At Visit 2 (after PDE5i washout), SEP Q2, "Were you able to insert your penis intoyour partner's vagina?" answered "YES" 0 - 50% of the time.
11. At Visit 2, SEP Q3, "Did your erection last long enough for you to have successfulintercourse?" answered "YES" 0 - 25% of the time.

Exclusion Criteria:

1. Previous major pelvic surgery or pelvic trauma that could impact erectile function,such as radical prostatectomy, radical cystectomy, rectal surgery. Patients withprevious TURP surgery without sequelae of iatrogenic ED may be included.
2. Previous penile surgery of any kind except circumcision and condyloma removal, such aspenile lengthening, penile cancer surgery, penile plication, grafting.
3. Previous history of priapism or penile fracture
4. Previous radiation therapy to pelvis.
5. Abnormal serum testosterone level defined as a value lower than 300 ng/dL (indicativeof untreated hypogonadism), or greater than 1197 ng/dL.
6. 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.
7. ED due primarily to psychogenic factors.
8. Peyronie's Disease or penile curvature that negatively influences sexual activity.
9. Patients with cardiac or non-cardiac electrical devices implanted.
10. Open wound or any anatomical or neurological abnormalities in the treatment area.
11. Uncontrolled diabetes mellitus with glucose >200 mg/dL (once or more times/week duringthe last month prior to recruitment, or during screening blood test).
12. Patients with generalized polyneuropathy, or neurological conditions irrespective ofcause, such as severe diabetes, multiple sclerosis or Parkinson 's disease.
13. Refusal to suspend ED therapy for duration of study. Subjects who are using Tadalafilas a treatment for BPH (Benign Prostatic Hyperplasia) will also be excluded.
14. Men deemed not healthy enough to participate in sexual activity.
15. Any condition or behavior that indicates to the Principal Investigator that thesubject is unlikely to be compliant with study procedures and visits.
16. Any health history or laboratory result that indicates to the Principal Investigatorthat the subject has a significant medical condition and should not participate in thestudy.
17. Known allergy to ultrasound gel. 18,. Any history of significant psychiatric disease,such as bipolar disorder or psychosis, greater than one lifetime episode of majordepression, current depression of moderate or greater severity. Patients who arecurrently using SSRI or psychotropic medications e.g., Citalopram (Celexa),Escitalopram (Lexapro, Cipralex), Paroxetine (Paxil, Seroxat), Fluoxetine (Prozac),Fluvoxamine (Luvox, Faverin),Sertraline (Zoloft, Lustral), Clonazepam (Klonopin),Alprazolam (Xanax), Aripiprazole (Ambilify), Clozapine (Clozaril), Risperidone (Risperdal), Quetiapine (Seroquel), Olanzapine (Zyprexa) are also excluded.
18. Partners who are < 18 years of age, who are nursing, who are known to be pregnant atscreening, who wish to become pregnant during the study period, who have any gynecologicproblems, sexual dysfunction, or major medical conditions that would limit participation insexual intercourse.
19. History of adverse events in response to tadalafil, which would prevent patientcompliance to the study protocol.