Evaluation of Tadalafil Combined with LIPUS for Treating Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Interventions
- Device: LIPUS (Low Intensity Pulsed Ultrasound)
- Registration Number
- NCT06543628
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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 randomized controlled trial.
- 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 ultrasound (LIPUS), a non-invasive therapy, improves the pathological changes in the corpora cavernosa and penile hemodynamics by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 114
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Tadalafil 5mg Participants will take tadalafil once daily at a dose of 5 mg for 6 months. Treatment group LIPUS (Low Intensity Pulsed Ultrasound) 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. Treatment group Tadalafil 5mg 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.
- Primary Outcome Measures
Name Time Method MCID based on IIEF-5 0 months, 2 months, 4 months, 6 months The primary outcome measure is based on the Minimum Clinically Important Difference (MCID) derived from the International Index of Erectile Function-5 (IIEF-5) scores. The MCID will be determined by the changes in IIEF-5 scores at 0 months, 2 months, 4 months, and 6 months. The IIEF-5 scale ranges from a minimum of 5 to a maximum of 25, with higher scores indicating better erectile function.
- Secondary Outcome Measures
Name Time Method IIEF-5 Score 0 months, 2 months, 4 months, 6 months The secondary outcome measure is the change in the International Index of Erectile Function-5 (IIEF-5) scores at 0 months, 2 months, 4 months, and 6 months. The scale is titled International Index of Erectile Function-5 (IIEF-5), with a minimum score of 5 and a maximum score of 25. The interpretation of the scores is that higher scores indicate better erectile function.
YM value at the tip of the corpus cavernosum 0 months, 6 months The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months.
EDV 0 months, 6 months The change in End-Diastolic Velocity (EDV) measured by Doppler ultrasound at 0 months and 6 months.
EHS 0 months, 2 months, 4 months, 6 months The scale title is Erection Hardness Score (EHS), with a minimum value of 1 and a maximum value of 4. A higher score indicates better erection hardness. The changes in the EHS will be measured at 0 months, 2 months, 4 months, and 6 months.
PSV 0 months, 6 months The change in Peak Systolic Velocity (PSV) measured by Doppler ultrasound at 0 months and 6 months.
YM value at the base of the corpus cavernosum 0 months, 6 months The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months.
Trial Locations
- Locations (1)
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳HangZhou, Zhejiang, China