Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction

NCT06543628 | Completed

• 1 other identifier: 2024-0401
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Tadalafil; LIPUS; Randomized Controlled Trial; protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• IIEF-5 Score

  0 months, 2 months, 4 months, 6 months

• EHS

  0 months, 2 months, 4 months, 6 months

• PSV

  0 months, 6 months

• EDV

  0 months, 6 months

• YM value at the tip of the corpus cavernosum

  0 months, 6 months

Study Arms (2)

Treatment group

EXPERIMENTAL

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; Device: LIPUS (Low Intensity Pulsed Ultrasound)

Control group

ACTIVE COMPARATOR

Participants will take tadalafil once daily at a dose of 5 mg for 6 months.

Drug: Tadalafil 5mg

Interventions

Tadalafil 5mg DRUG

Participants will take tadalafil once daily at a dose of 5 mg for 6 months.

Also known as: Cialis

Control group; Treatment group

LIPUS (Low Intensity Pulsed Ultrasound) DEVICE

Participants will receive LIPUS treatment applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment.

Treatment group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Zhang Q, Lv B, Yu H, Fu Y, Xu R, Liao Z, Zhang X, Fu Y, Huang W, Huang X. Evaluation of tadalafil in combination with Low-Intensity Pulsed Ultrasound (LIPUS) for erectile dysfunction: a protocol for a randomized controlled trial (SPIRIT Compliant). Trials. 2025 Nov 25;26(1):591. doi: 10.1186/s13063-025-09298-4.

  PMID: 41291823 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Bodong Lv, MD

  2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Separate the person responsible for randomization and assignment from the outcome assessor, ensure that the evaluator does not have access to information for the participant group, and assign a unique code to the participant, and the evaluator is only exposed to the code without knowing the specific intervention behind it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 11, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 3, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)