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Objective: To investigate the effect of low-intensity pulsed ultrasound(LIPUS)as a treatment for erectile dysfunction(ED)in a rat model of type Ⅰ diabetes mellitus(DM)induced by streptozotocin(STZ).Methods: Seventy male Sprague-Dawley rats were randomly assigned to two cohorts: a normal control(NC)group and a STZ-induced DM group,which was further sub-divided into DM,DM + LIPUS 100,DM + LIPUS 200 and DM + LIPUS 300 groups and a DM+LESWT(low-energy shock wave therapy)300 positive control group.Animals in the LIPUS subgroups were treated at different energy levels(100,200,300 mW/cm2)for 3 min,and animals in the LESWT group received 300 shocks at 0.09 mJ/mm2.All procedures were repeated 3 times per week for 2 weeks.After a 2-week wash-out period,intracavernous pressure(ICP)was measured;the midpenile region was examined histologically;and VEGF,αSMA,eNOS and nNOS expression,and activity of the TGF-β1/Smad/CTGF signaling pathway were examined in penile tissue by Western blot analysis.Results: LIPUS therapy significantly improved erectile function in diabetic rats,as evidenced by enhanced ICP levels,increased endothelial and smooth muscle content,a higher collagen I/collagen Ⅲ ratio,increased quantity of elastic fibers,and elevated eNOS and nNOS expression.Interestingly,LIPUS was also associated with downregulation of the TGF-β1/Smad/CTGF signaling pathway in penile tissue,whose activation is correlated with ED pathology.Conclusions: LIPUS therapy improved erectile function and reversed pathological changes in penile tissue of STZinduced diabetic rats.LIPUS therapy has potential as a non-invasive therapy for diabetic ED in the clinic.