Status:
COMPLETED
Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Erectile Dysfunction
Eligibility:
MALE
21-65 years
Phase:
NA
Brief Summary
This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (LIPUS) in patients with erectile dysfunction (ED) through a rando...
Detailed Description
Erectile dysfunction (ED) is defined as the persistent inability to achieve and maintain a sufficient erection for satisfactory sexual performance for more than six months. Low-intensity pulsed ultras...
Eligibility Criteria
Inclusion
- Age between 21 and 65 years old.
- An International Index of Erectile Function-5 (IIEF-5) score of 21 or less.
- First-time diagnosis of erectile dysfunction (ED) without prior treatment from traditional Chinese or Western medicine.
- A stable heterosexual relationship for at least 3 months.
- Agreement to attempt sexual intercourse at least four times every four weeks during the study period.
- Signing of an informed consent form.
Exclusion
- Erectile dysfunction caused by spinal/neural injury or radical prostatectomy.
- History of priapism or penile anatomical abnormalities.
- Use of a penile prosthesis.
- Severe and poorly controlled psychological disorders.
- Untreated endocrine disorders, such as hypogonadism, hypothyroidism, or pituitary dysfunction.
- History of myocardial infarction, stroke, life-threatening arrhythmias, or potential cardiovascular risks during sexual activity within the six months prior to enrollment.
- Inability to complete the participant records required for the trial.
- Allergic constitution and multiple drug allergies.
Key Trial Info
Start Date :
August 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06543628
Start Date
August 11 2024
End Date
March 3 2025
Last Update
March 10 2025
Active Locations (1)
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1
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009