Low-intensity pulsed ultrasound for erectile dysfunction: a systematic review and limited quantitative synthesis

Low-intensity pulsed ultrasound (LIPUS) is a non-invasive therapy for erectile dysfunction (ED), but evidence is geographically concentrated, heterogeneous, and largely patient-reported. Because LIPUS differs biophysically from low-intensity extracorporeal shockwave therapy (Li-ESWT), this review evaluated short-term efficacy, safety, and protocol evidence without cross-modality pooling.

Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 principles, we searched PubMed/MEDLINE, Embase, Web of Science, Cochrane Library, Scopus, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), China National Knowledge Infrastructure (CNKI), Wanfang Data, the VIP Journal Integration Platform (VIP), the Chinese Biomedical Literature Database (SinoMed), and references through 8 June 2026. Clinical studies of adult men with ED receiving LIPUS were eligible; Li-ESWT-only and non-human studies were excluded. This systematic review was re-registered in OSF Registries on 2 September 2026 (updated ID: 7b9ed; https://osf.io/7b9ed/) after the original record (former ID: 7s9kF) became inaccessible due to technical link failure, with no core protocol modifications. Literature search was completed on 8 June 2026 before data synthesis; no eligibility criteria, outcomes, or effect estimates were altered post-extraction. Two reviewers screened, extracted data, assessed risk of bias with design-appropriate tools, and rated certainty using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

Six Chinese studies involving 659 participants were included. One double-blind sham-controlled randomized trial provided the main efficacy evidence. At 12 weeks, LIPUS improved the five-item International Index of Erectile Function (IIEF-5) score versus sham (mean difference =3.38, 95% confidence interval: 2.60-4.16) and increased clinically meaningful response (risk ratio =3.38, 95% confidence interval: 1.78-6.39; 67.5% vs. 20.0%); certainty was low. Two randomized studies compared three versus two weekly sessions with a fixed total number; Chen et al. [2022] met source-defined non-inferiority margins, but did not establish equivalence, superiority, optimal dosing, or cross-device generalizability. Combination/adjuvant evidence was heterogeneous and narratively synthesized. Complete penile Doppler data were available in only six participants. No serious device-related adverse event or discontinuation was reported; follow-up was no longer than 12 weeks.

Based on current low-certainty evidence, LIPUS remains investigational and cannot be recommended for routine clinical use in ED at this time. International multicenter sham-controlled trials with standardized acoustic reporting, objective hemodynamic endpoints, transparent adverse-event assessment, and 3-, 6-, and 12-month follow-up are needed.