Erectile dysfunction
Conditions
Interventions
Experimental group:Intracavernous injection of vasoactive drugs with a needle-free injector(two doses)
Experimental group:Intracavernous injection of vasoactive drugs with a needle-free injector
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-60, male; 2.Diagnosed with erectile dysfunction, with an IIEF-5 score of =21 points and a duration of more than 3 months; 3.Volunteer to participate in the trial and sign informed consent;
Exclusion criteria
Exclusion criteria: 1. Erectile dysfunction caused by trauma; 2. Combined with genitourinary tract infection or systemic infection, which is judged by the investigator to be unsuitable for participating in this trial; 3. Combined with clinically significant penile deformities judged by the investigator, such as micropenis, penile curvature, cavernous body fibrosis, etc.; 4. History of sexually transmitted diseases such as syphilis and HIV; 5. History of previous penile surgery (except circumcision); 6. History of severe cardiovascular and cerebrovascular diseases such as coronary heart disease, stroke, cardiogenic shock, heart failure, etc., requiring hospitalization in the past 6 months; or history of previous cardiac surgery; 7. Combined with poorly controlled hypertension or diabetes mellitus: blood pressure cannot be controlled within the normal range after taking the drug; Fasting blood glucose exceeding the upper limit of normal by 1.5 times; 8. Combined with severe hepatic and renal insufficiency: AST or ALT exceeds 2 times the upper limit of normal; Need to undergo blood purification treatment such as dialysis; 9. History of symptomatic orthostatic hypotension and recurrent syncope; 10. Significant adverse reactions after prior oral PDE5i therapy; 11. Known or suspected history of allergy to alprostadil, papaverine, or phentolamine; 12. Are taking anticoagulant drugs, or have coagulation dysfunction: APTT and INR are both more than 1.5 times the upper limit of normal; 13. Have taken other drugs for the treatment of erectile dysfunction in the past 1 week and the drug treatment is effective; 14. Have taken nitric oxide donor drugs or monoamine oxidase inhibitors within the past 24 hours or need to take them during the trial period; 15. Combined with severe mental disorders, unable to cooperate; or poor compliance, unwilling or unable to complete treatment and follow-up; 16. Is participating in other interventional clinical trials; 17. The investigator is not suitable to participate in this trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pain score;Onset time;Erection duration; | — |
Primary
| Measure | Time frame |
|---|---|
| Changes in EHS from baseline after injection;effective rate; | — |
Countries
China
Contacts
Public ContactJihong Liu
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed