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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
Participants will receive LIPUS treatment applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment.
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
MCID based on IIEF-5
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.
Time frame: 0 months, 2 months, 4 months, 6 months
IIEF-5 Score
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.
Time frame: 0 months, 2 months, 4 months, 6 months
EHS
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.
Time frame: 0 months, 2 months, 4 months, 6 months
PSV
The change in Peak Systolic Velocity (PSV) measured by Doppler ultrasound at 0 months and 6 months.
Time frame: 0 months, 6 months
EDV
The change in End-Diastolic Velocity (EDV) measured by Doppler ultrasound at 0 months and 6 months.
Time frame: 0 months, 6 months
YM value at the tip of the corpus cavernosum
The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months.
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Time frame: 0 months, 6 months
YM value at the base of the corpus cavernosum
The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months.
Time frame: 0 months, 6 months