Alonso-Isa Manuel, García-Gómez Borja, García-Rojo Esther, Peña-Vallejo Elena, Caro-González Maria Del Prado, Juste-Álvarez Silvia, Calzas-Montalvo Cristina, Sopeña-Sutil Raquel, Rodríguez-Antolín Alfredo, Romero-Otero Javier
Department of Urology, Universitary Hospital 12 de Octubre, Madrid, 28041, Spain.
Department of Urology, Universitary Hospital HM Puerta del Sur, Madrid, 28938, Spain.
J Sex Med. 2025 Jun 29;22(7):1115-1121. doi: 10.1093/jsxmed/qdaf090.
Premature ejaculation (PE) is a common sexual dysfunction that negatively impacts the quality of life and relationships for men.
To compare the effectiveness, side effects, and satisfaction between a novel cognitive-behavioral therapy based on sphincter control training (SCT) supported by a mechanical masturbation device and dapoxetine, a pharmacological treatment for PE.
A crossover study with 20 male patients diagnosed with PE was designed. Participants were randomly assigned to start with an 8-week cognitive-behavioral therapy program supported by a masturbation device or an 8-week treatment with dapoxetine (60 mg). After a 2-week washout time, treatments were crossed. Effectiveness was measured through intravaginal ejaculation latency time (IELT), Premature Ejaculation Diagnostic Tool (PEDT) scores, and the International Index of Erectile Function. Satisfaction rates were measured using the Erectile Dysfunction Inventory of Treatment Satisfaction scale and Likert scale. Adverse effects were recorded for both treatments.
Changes in IELT, PEDT scores, satisfaction rates, and side effects.
In the randomized phase, SCT + device demonstrated superior outcomes compared to dapoxetine for PEDT scores: 15.2 (SD = 1.7) vs 18.4 (SD = 2.6), P = .01; though IELT improvements were comparable: 111.7 (SD = 56.7) seconds vs 91.8 (SD = 77.8) seconds, P = .20. After crossover, patients switching from dapoxetine to SCT + device achieved significantly greater IELT 171.8 (SD = 148.8) seconds vs 76.7 (SD = 37.1) seconds, P = .02; and better PEDT scores: 14.6 (SD = 2.7) vs 17.7 (SD = 2.7), P = .04. Notably, dapoxetine underperformed relative to historical data. Treatment satisfaction was markedly higher with SCT + device: 64.9% (SD = 9.3) vs 33.3% (SD = 20.7), P = .003; with fewer adverse effects (25% vs 60%).
This pilot study suggests a potential role for cognitive-behavioral therapy supported by a mechanical masturbation device in managing PE, but further research is needed to confirm its effectiveness and comparative advantages.
The main strengths of the study is its crossover design, which minimizes the influence of individual patient variability. Limitations include the small sample size, the lack of long-term follow-up to assess the durability of treatment effects, and the absence of a sham arm using masturbation alone, which makes it unclear whether the observed improvements are due to the device itself or the act of masturbating.
This pilot study suggests that the cognitive-behavioral therapy program supported by the male masturbation device may offer potential benefits for managing PE, but further research with larger samples is needed to confirm these preliminary findings.
早泄（PE）是一种常见的性功能障碍，对男性的生活质量和人际关系产生负面影响。
比较基于机械自慰装置支持的括约肌控制训练（SCT）的新型认知行为疗法与达泊西汀（一种治疗PE的药物）在疗效、副作用和满意度方面的差异。
设计了一项针对20名被诊断为PE的男性患者的交叉研究。参与者被随机分配，开始为期8周的由自慰装置支持的认知行为疗法项目或为期8周的达泊西汀（60毫克）治疗。经过2周的洗脱期后，治疗进行交叉。通过阴道内射精潜伏期（IELT）、早泄诊断工具（PEDT）评分和国际勃起功能指数来衡量疗效。使用治疗满意度勃起功能障碍量表和李克特量表来测量满意度。记录两种治疗的不良反应。
在随机阶段，对于PEDT评分，SCT+装置显示出优于达泊西汀的结果：15.2（标准差=1.7）对18.4（标准差=2.6），P=0.01；尽管IELT的改善相当：111.7（标准差=56.7）秒对91.8（标准差=77.8）秒，P=0.20。交叉后，从达泊西汀转换为SCT+装置的患者实现了显著更长的IELT：171.8（标准差=148.8）秒对76.7（标准差=37.1）秒，P=0.02；以及更好的PEDT评分：14.6（标准差=2.7）对17.7（标准差=2.7），P=0.04。值得注意的是，达泊西汀相对于历史数据表现不佳。SCT+装置的治疗满意度明显更高：64.
