NCT06543628

Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction

Tadalafil Combined With Low-Energy Pulsed Ultrasound (LIPUS) for the Treatment of Erectile Dysfunction: A Prospective, Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: Male
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	Tadalafil 5mg	Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
DEVICE	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.

Timeline

• Start date: 2024-08-11
• Primary completion: 2025-03-01
• Completion: 2025-03-03
• First posted: 2024-08-09
• Last updated: 2025-03-10

Locations

1 site across 1 country: China