Male Erectile Dysfunction
Conditions
Interventions
LIPUS treatment group:LIPUS therapy was delivered twice a week for a total of 8 sessions (within a one-month period).
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients must be willing and able to provide informed consent. 2.Aged 30-80 years; 3.Currently taking PDE5 inhibitors (PDE5i) but with no effect; 4.Patients with an IIEF-Erectile Function (EF) score <= 10; 5.Diabetic patients with HgbA1C levels <= 7.5% within the last month prior to enrollment; 6.History of ED for more than 3 months but less than 10 years; 7.Vasculogenic ED caused by penile arterial and/or cavernosal lesions, with abnormal 8.findings on penile Doppler ultrasound vascular testing; 9.Have a stable heterosexual partner.
Exclusion criteria
Exclusion criteria: 1.Endocrine ED caused by severe endocrine disorders or abnormal sex hormone levels, or ED due to central nervous system factors, such as Alzheimer's disease or Parkinson's disease. 2.Patients with severe anxiety or depression. 3.Any patient with severe psychological disorders, spinal cord injury, penile anatomical abnormalities, or diagnosed with penile hemangioma. 4.Clinically significant chronic hematological diseases, or severe respiratory, digestive, or central nervous system disorders. 5. Recovering from cancer within the past year or having undergone radiation therapy in the pelvic region. 6.Use of anti-androgen or androgenic medications; medication-induced ED due to coagulation disorders and use of anticoagulants (e.g., Coumadin), or testosterone levels 1000 ng/dL within the last month. 7. Participation in any other clinical study involving medical devices or drugs within the past 3 months; or other conditions deemed unsuitable for participation in this trial by the investigator. 8. History of radical prostatectomy or extensive pelvic surgery, including surgeries for bladder cancer and colorectal cancer. 9. Penile anatomical deformities, including Peyronie’s disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF-EF scores;NPT testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sexual Encounter Profile (SEP) – Questions 2 and 3;Erection hardness grading scale, EHS;Penile Erection Satisfaction;General Assessment Questionnaire; | — |
Countries
China
Contacts
Public ContactZheng Li
Shanghai General Hospital
Outcome results
None listed