The Effectiveness of Negative Pressure Physical Therapy in the Management of Nonorganic Erectile Dysfunction: A Multicenter Randomized Controlled Trial

Background: Erectile dysfunction (ED) is a common male sexual dysfunction characterized by the inability to achieve and maintain an erection sufficient for satisfactory sexual performance. Current therapeutic approaches for this condition have certain limitations. Objectives: This study aims to investigate the efficacy of negative pressure physical therapy (NPPT) in the rehabilitation and treatment of nonorganic ED. Methods: This protocol divides subjects into two groups based on different intervention conditions. The experimental group received tadalafil every night before sleep along with the use of a male sexual function therapeutic device, whereas the control group received only tadalafil every night before sleep. A total of 124 patients were enrolled. The recovery and treatment efficacy for sexual dysfunction were evaluated by assessing improvements in erectile difficulty, penile circumference, and penile length. Results: In the full analysis set (FAS), the estimated mean change in IIEF‐5 scores was 4.92 points in the experimental group and 3.13 points in the control group, resulting in a between‐group difference of 1.79 points. In the per‐protocol set (PPS), the estimated mean change was 4.96 points in the experimental group versus 3.01 points in the control group, with a between‐group difference of 1.95 points. In the analysis of changes in penile girth, the experimental group exhibited a mean increase of 0.32 cm (standard deviation SD ± 0.44), which was significantly greater than the control group’s increase of 0.14 cm. In the subsequent follow‐up 2, the mean girth change in the experimental group further increased to 0.49 cm (SD ± 0.71), whereas the control group showed only a 0.02 cm change; the PPS analysis yielded results consistent with the FAS. Regarding penile length, at follow‐up 1, the experimental group demonstrated a mean increase of 0.51 cm (SD ± 0.81), significantly higher than the control group’s 0.19 cm (SD ± 0.32). At follow‐up 2, the experimental group’s mean length change rose to 0.39 cm (SD ± 0.45), while the control group exhibited virtually no change (0.00 cm, SD ± 0.05), with the between‐group difference being extremely significant ( p < 0.0001). Discussion and Conclusion: NPPT combined with tadalafil exhibited significantly superior efficacy in treating nonorganic ED, providing a safe and effective nonpharmacological option for clinical use.