Erectile Dysfunction
Conditions
Interventions
Experimental group:Daily 5mg Tadalafil Combined with Low-Intensity Pulsed Ultrasound Therapy Twice a Week
Control group:Daily 5mg Tadalafil
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medical diagnostic criteria for male erectile dysfunction; (2) Male, aged between 18 and 65 years; (3) No use of Chinese or Western medications for erectile dysfunction in the past two weeks; (4) Have had a stable heterosexual relationship for =3 months; (5) Agree to attempt intercourse at least four times every four weeks during the trial period; (6) Have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Poorly controlled diabetes (fasting blood glucose >120% of the upper limit of normal). 2. Erectile dysfunction due to spinal cord/nerve injury or radical prostatectomy. 3. History of persistent penile erection or anatomical abnormalities of the penis (e.g., penile curvature, corporal fibrosis, or Peyronie's disease) or prone to abnormal penile erections (e.g., sickle cell anemia, multiple myeloma, or leukemia). 4. Use of penile prosthesis. 5. Severe psychological abnormalities that are not well controlled. 6. Untreated endocrine diseases such as hypogonadism, hypothyroidism, or hypopituitarism. 7. Hypogonadism currently undergoing androgen replacement therapy but not stabilized for more than 3 months. 8 .Patients with myocardial infarction, stroke, life-threatening arrhythmias, or potential cardiovascular risks during sexual activity within 6 months prior to enrollment, including but not limited to significant ECG abnormalities judged by the investigator, history of coronary artery revascularization, unstable angina, angina during intercourse, congestive heart failure, significant cardiomyopathy, moderate or severe cardiovascular disease, etc. 9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2 times the upper limit of normal; creatinine greater than 2 times the upper limit of normal. 10. Patients with bleeding disorders or active gastrointestinal ulcers. 11. Patients with resting hypotension (blood pressure 170/100 mmHg). 12. History of alcohol abuse (weekly alcohol consumption >14 units; one unit equals one 350 mL bottle of beer, 120 mL of wine, or 30 mL of 40% spirit) or drug abuse within the past 6 months. 13. Unable to comply with the subject records required for the trial. 14. Patients with significant comorbidities. 15. Those with an allergic constitution and multiple drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-item international index of erectile function; | — |
Secondary
| Measure | Time frame |
|---|---|
| erectile hardness score;Erectile dysfunction-item international index of erectile function;Peak Systolic Velocity;End Diastolic Velocity;oung's Modulus in Shear Wave Elastography; | — |
Countries
China
Contacts
Public ContactBodong Lv
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed