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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Tadalafil 5mg; Device: LIPUS (Low Intensity Pulsed Ultrasound)

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310009
      • The 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tadalafil 5mg; Participants will take tadalafil once daily at a dose of 5 mg for 6 months.; Other Names: Cialis; 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.
Active Comparator: Control group; Participants will take tadalafil once daily at a dose of 5 mg for 6 months.	Drug: Tadalafil 5mg; Participants will take tadalafil once daily at a dose of 5 mg for 6 months.; Other Names: Cialis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 months, 2 months, 4 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSV	The change in Peak Systolic Velocity (PSV) measured by Doppler ultrasound at 0 months and 6 months.	0 months, 6 months
EDV	The change in End-Diastolic Velocity (EDV) measured by Doppler ultrasound at 0 months and 6 months.	0 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.	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.	0 months, 2 months, 4 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.	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.	0 months, 6 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Bodong Lv, MD, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Tadalafil; protocol; LIPUS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Vasodilator Agents; Urological Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Tadalafil
• Other Study ID Numbers: 2024-0401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No