A prospective and comparative evaluation of a male masturbation device for premature ejaculation—functional outcomes, safety, and satisfaction assessment: a pilot study

BACKGROUND: Premature ejaculation (PE) is a common sexual dysfunction that negatively impacts the quality of life and relationships for men. AIM: 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. METHODS: 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. OUTCOMES: Changes in IELT, PEDT scores, satisfaction rates, and side effects. RESULTS: 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%). CLINICAL IMPLICATIONS: 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. STRENGTHS AND LIMITATIONS: 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. CONCLUSION: 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.