Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction
NCT ID: NCT06543628
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2024-08-11
2025-03-03
Brief Summary
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Detailed Description
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This study will recruit 114 patients diagnosed with ED and use simple random sampling to allocate them into a treatment group and a control group in a 1:1 ratio. The treatment group will receive daily 5mg tadalafil combined with LIPUS therapy twice a week for 4 weeks, followed by a 4-week interval without LIPUS treatment, and then repeat the treatment. The control group will receive only daily 5mg tadalafil.
Efficacy will be evaluated primarily through the minimal clinically important difference (MCID) of the International Index of Erectile Function-5 (IIEF-5) at each follow-up point, combined with Erectile Hardness Score (EHS), penile blood flow parameters, and elasticity values for comprehensive assessment.
This trial may provide additional clinical evidence for the efficacy, safety, and cost-effectiveness of tadalafil combined with LIPUS in treating ED patients. The inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ED symptoms with histological assessment, providing new methods for efficacy evaluation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment group
Participants will take tadalafil once daily at a dose of 5 mg for 6 months, in combination with LIPUS applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment.
Tadalafil 5mg
Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
LIPUS (Low Intensity Pulsed Ultrasound)
Participants will receive LIPUS treatment applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment.
Control group
Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
Tadalafil 5mg
Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
Interventions
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Tadalafil 5mg
Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
LIPUS (Low Intensity Pulsed Ultrasound)
Participants will receive LIPUS treatment applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
21 Years
65 Years
MALE
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Bodong Lv, MD
Role: STUDY_CHAIR
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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2024-0401
Identifier Type: -
Identifier Source: org_study_id
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