ArticleTrials2025
Evaluation of tadalafil in combination with Low-Intensity Pulsed Ultrasound (LIPUS) for erectile dysfunction: a protocol for a randomized controlled trial (SPIRIT Compliant).
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06543628 (Tadalafil Combined With Low-Energy Pulsed Ultrasound), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Tadalafil Combined With Low-Energy Pulsed Ultrasound (LIPUS) for the Treatment of Erectile Dysfunction: A Prospective, Randomized Controlled Clinical Trial
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
backgroundErectile dysfunction (ED) is characterized by a persistent inability to achieve and maintain sufficient penile erection for satisfactory sexual performance persisting for at least six months. Low-intensity pulsed ultrasound (LIPUS), a noninvasive therapy, has shown potential in improving ED by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation. This study aims to evaluate the clinical efficacy and histological changes in the corpus cavernosum of patients with ED treated with tadalafil combined with LIPUS through a randomized controlled trial.
methodsThis study will enroll 114 patients diagnosed with ED who will be randomly assigned to either the treatment group or the control group in a 1:1 ratio using simple random sampling. The treatment group will first receive 5 mg of tadalafil daily combined with twice-weekly LIPUS therapy for 4 weeks. Following a 4-week interval with daily 5 mg tadalafil alone (no LIPUS treatment), the same combined treatment regimen will be repeated. The control group will receive only 5 mg of tadalafil daily. The primary outcome will be assessed using the minimal clinically important difference (MCID) based on the International Index of Erectile Function-5 (IIEF-5) at each follow-up visit. Additional assessments will include the Erection Hardness Score (EHS), penile blood flow parameters, and elasticity values for a comprehensive evaluation. DISCUSSION: The study aims to evaluate the efficacy of tadalafil combined with LIPUS for treating ED and to improve the evaluation of treatment response in erectile dysfunction by integrating blood flow parameters and two-dimensional shear wave elastography.
trial registrationTrial registration: ClinicalTrials.gov, NCT06543628. Registered 5th August 2024, https://clinicaltrials.gov/study/NCT06543628 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.