The Effectiveness of Negative Pressure Physical Therapy in the Management of Nonorganic Erectile Dysfunction: A Multicenter Randomized Controlled Trial
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Abstract
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.
背景：勃起功能障碍（ED）是一种常见的男性性功能障碍，其特征是无法达到和维持足以满足性行为的勃起。目前的治疗方法有一定的局限性。目的：探讨负压物理疗法（NPPT）在非器质性ed康复治疗中的疗效。方法：本方案根据不同的干预条件将受试者分为两组。实验组每晚睡前服用他达拉非，同时使用男性性功能治疗仪，而对照组每晚睡前只服用他达拉非。共有124名患者入组。通过评估勃起困难、阴茎周长和阴茎长度的改善来评估性功能障碍的恢复和治疗效果。结果：在全分析集（FAS）中，实验组IIEF-5评分的估计平均变化为4.92分，对照组为3.13分，组间差异为1.79分。在每方案集（PPS）中，实验组的估计平均变化为4.96分，对照组为3.01分，组间差异为1.95分。在阴茎周长变化分析中，实验组平均增加0.32 cm（标准差[SD]±0.44），明显大于对照组增加0.14 cm。在随后的随访2中，实验组的平均周长变化进一步增大至0.49 cm (SD±0.71)，而对照组仅变化0.02 cm；PPS分析的结果与FAS一致。在随访1时，实验组阴茎长度平均增加0.51 cm (SD±0.81)，明显高于对照组的0.19 cm （SD±0.32）。随访2时，实验组平均长度变化为0.39 cm (SD±0.45)，对照组基本无变化（0.00 cm, SD±0.05），组间差异极显著（p < 0.0001）。讨论与结论：NPPT联合他达拉非治疗非器质性ED的疗效显著优于非器质性ED，为临床应用提供了安全有效的非药物选择。
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