Evaluation of Tadalafil in Combination with Low-Intensity Pulsed Ultrasound (LIPUS) for Erectile Dysfunction: A Protocol for a Randomized Controlled Trial (SPIRIT Compliant)

Evaluation of Tadalafil in Combination with Low-Intensity Pulsed Ultrasound (LIPUS) for Erectile Dysfunction: A Protocol for a Randomized Controlled Trial (SPIRIT Compliant) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Evaluation of Tadalafil in Combination with Low-Intensity Pulsed Ultrasound (LIPUS) for Erectile Dysfunction: A Protocol for a Randomized Controlled Trial (SPIRIT Compliant) Qi Zhang, Bodong Lv, Haojie Yu, Yuli Fu, Runnan Xu, Zedong Liao, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5133635/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 25 Nov, 2025 Read the published version in Trials → Version 1 posted 3 You are reading this latest preprint version Abstract Background Erectile 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. Methods This 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 registration : Trial registration: ClinicalTrials.gov, NCT06543628. Registered 5th August 2024, https://clinicaltrials.gov/study/NCT06543628 Erectile Dysfunction Low-Intensity Pulsed Ultrasound (LIPUS) Tadalafil Randomized Controlled Trial Protocol Full Text Supplementary Files ResponsetoReviewersforManuscriptTRLSD2401267R2.docx SPIRITChecklistRevised.doc Cite Share Download PDF Status: Published Journal Publication published 25 Nov, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Accept 10 Nov, 2025 Editor assigned by journal 05 Oct, 2025 First submitted to journal 22 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5133635","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":524821351,"identity":"1b12cbcb-2342-42db-8a65-cab38d20597f","order_by":0,"name":"Qi Zhang","email":"","orcid":"","institution":"The Second Affiliated Hospital of Zhejiang University School of Medicine: Zhejiang University School of Medicine Second Affiliated Hospital","correspondingAuthor":false,"prefix":"","firstName":"Qi","middleName":"","lastName":"Zhang","suffix":""},{"id":524821352,"identity":"79679153-2250-43e3-9b01-efc8dbaa118c","order_by":1,"name":"Bodong 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