1. Introduction

Premature ejaculation (PE) is one of the most common forms of male sexual dysfunction, typically characterized by ejaculation that always or almost always occurs before vaginal penetration or within approximately one minute after penetration, accompanied by a persistent inability to delay ejaculation [1, 2]. Epidemiological surveys conducted in China have reported PE prevalence rates of up to 25.8% [3]. Beyond impairment of sexual function, PE negatively affects mental health, quality of life, and intimate relationships, and is therefore frequently accompanied by anxiety, depression, and reduced self-esteem [4].

Current therapeutic options for PE include pharmacotherapy, topical anesthetics, behavioral interventions, and surgery [5]. Selective serotonin reuptake inhibitors (SSRIs), which are considered first-line pharmacologic agents, have been shown to prolong intravaginal ejaculatory latency time (IELT) by increasing synaptic 5-hydroxytryptamine (5-HT); however, they are often associated with adverse effects such as fatigue, nausea, and other dose-limiting symptoms [6]. Topical anesthetics (e.g., lidocaine cream) can decrease penile sensitivity and provide a relatively rapid onset of action, yet may also induce penile numbness and diminish the sexual sensation of the partner. Additionally, behavioral techniques, such as the stop-start method, have demonstrated efficacy in principle but are challenging to implement consistently over the long term. In this regard, surgical procedures, including selective dorsal penile nerve neurectomy, may increase IELT, but carry the risks of persistent penile numbness and erectile dysfunction [7].

In recent years, neuromodulation has drawn increasing clinical interest as a non-pharmacologic, repeatable, and mechanistically rational approach. The pudendal nerve is a key peripheral component of the ejaculatory reflex, with its functional state closely linked to ejaculatory control. Peripheral nerve stimulation directed at the pudendal nerve has been applied in various pelvic floor disorders and is now being investigated for the treatment of PE. Concurrently, acupuncture, one of the most representative modalities of traditional Chinese medicine, has an important role in the integrative management of PE [8, 9]. Repetitive transcranial acupuncture stimulation (rTAS), proposed by Professor Shentian Sun, is a novel transcranial technique derived from traditional acupuncture. By stimulating scalp regions associated with affective regulation, rTAS is designed to modulate brain function and improve mood states. Given that emotional disturbances such as anxiety and tension are common in patients with PE and are closely related to the onset and fluctuation of symptoms, the application of rTAS in this population is of particular interest.

Given the complex and multifactorial etiology of PE, single treatment modality often yields suboptimal and unstable clinical outcomes. Since 2025, our hospital has implemented a combined neuromodulatory strategy using pudendal nerve electroacupuncture (PNEA) together with rTAS for the management of PE. Preliminary clinical observations have suggested that this integrated approach may provide more pronounced symptom relief than conventional single-modality interventions. In this present study, we investigate the combined PNEA + rTAS treatment protocol and evaluate its therapeutic effects in a randomized clinical trial.

2. Methods

2.3 Treatment protocols

The control group underwent PNEA only, whereas the observation group was given PNEA combined with rTAS. Both interventions were administered twice weekly for 8 consecutive weeks.

For rTAS, the target area was located over the anterior frontal region. Using the intersection of the anterior frontal line and the anterior–posterior midline as the central point of the frontal area, 1-cm line segments were drawn upward and downward along the anterior–posterior midline, and parallel line segments were then extended bilaterally at the same level, passing through the medial canthi. The region encompassed by these three parallel line segments was defined as the “cognitive-affective area” and served as the needling site (Fig. 1). The needle was accurately advanced into the subgaleal plane (beneath the galea aponeurotica). During manipulation, small-amplitude lift-thrust movements were used to elicit the arrival of qi, while high-frequency twirling at ≥200 rpm was applied. Each stimulation cycle lasted 3–5 minutes, with the intensity titrated to produce a distinct sensation of soreness and distension without pain, and the needles were retained after stimulation.

Fig. 1.rTAS protocol: scalp mapping and needling sites.

For PNEA, four points superior to the midpoint of the pubic symphysis were selected as pudendal nerve stimulation sites, with points on the same side aligned along the same neural conduction pathway. Using 0.40 mm × 100 mm needles, the pudendal nerve was approached percutaneously with slow, controlled advancement (Fig. 2). When the needle contacted the nerve, the patient experienced an electric shock-like sensation in the perineal region, and penile erection (mild engorgement) could occasionally be induced, at which point needle advancement was stopped. Each needle was then connected to a G6805-2 electroacupuncture device using a dense-disperse wave pattern. The stimulation intensity was adjusted to a level that the patient found comfortable, and needles were retained for 40 minutes.

Fig. 2.PNEA protocol: anatomical landmarks and needle path.

3. Results

3.1 Baseline characteristics

Between March and July 2025, a total of 120 men with PE were allocated using block randomization to either the observation group or the control group, with 60 patients in each group (Fig. 3). By week 8, 12 participants did not complete the 8-week treatment or follow-up and were excluded from the outcome analysis, leaving 53 participants in the observation group and 55 in the control group who completed the protocol. Week 8 was pre-specified as the primary assessment time point, at which IELT, PEDT, SDS, and SAS were compared both within groups (pre- vs. post-treatment) and between groups. The overall mean age of the cohort was 32.65 years. Initial analysis showed that baseline characteristics, including age, body mass index (BMI), and IIEF-5 scores, were well balanced between the two groups, supporting their comparability for subsequent efficacy analyses (Table 1).

Fig. 3.Study flow diagram. *, Seven patients in the observation group and five in the control group did not complete the 8-week treatment or follow-up and were excluded from the week-8 outcome analysis. PE: Premature ejaculation; PEDT: Premature Ejaculation Diagnostic Tool; IELT: intravaginal ejaculation latency time; SAS: Self-rating Anxiety Scale; SDS: Self-rating Depression Scale.

Table 1.Baseline characteristics of the study population.

Characteristics	Observation group (n = 53)	Control group (n = 55)	p-value
Age (yr)	32.38 ± 6.57	32.91 ± 3.79	0.61
BMI (kg/m2)	23.54 ± 2.87	23.70 ± 3.00	0.78
IIEF-5	24.0 (23.5, 25.0)	24.0 (23.0, 25.0)	0.89
Education
	Junior high or lower	12 (22.64%)	14 (25.50%)	0.85
	High school	15 (28.30%)	17 (30.91%)
	University	26 (49.06%)	24 (43.64%)
Smoking	28 (52.83%)	27 (49.10%)	0.85
Alcohol use	21 (39.62%)	26 (47.27%)	0.54
Married	33 (62.26%)	38 (69.10%)	0.59
Hypertension	4 (7.55%)	3 (5.45%)	0.96
Diabetes	4 (7.55%)	2 (3.64%)	0.64
Normally distributed continuous variables are expressed as mean ± standard deviation, non-normally distributed continuous variables as median (interquartile range), and categorical variables as number (percentage). BMI: Body Mass Index; IIEF-5: International Index of Erectile Function-5.

4. Discussion

In this randomized trial, the 8-week course of combined PNEA and rTAS significantly improved all measured outcomes in the observation group compared with baseline and were consistently greater than in the control group. The greater increase in IELT and larger reduction in PEDT scores in the observation group support rTAS for providing incremental efficacy in delaying ejaculation and alleviating PE-related symptom burden beyond that achieved by peripheral pudendal nerve stimulation alone. In parallel, the significant reductions in both SAS and SDS scores in the observation group suggest that central neuromodulation targeting cognitive-affective regions may contribute to mood stabilization, which may, in turn, facilitate further improvement in sexual function through reductions in performance anxiety and depressive symptoms. Although the control group did not receive a central neuromodulatory intervention, SAS scores also declined over the treatment period, a pattern that is plausibly attributable to partial improvement in ejaculatory symptoms and the resulting secondary reduction in anxiety.

When clinical response was evaluated using IELT-based categorical grading, overall response rates were high in both groups, and the numerically higher rate in the observation group did not reach statistical significance (p = 0.12). Given the limited sample size and the loss of information from categorizing a continuous endpoint, this analysis should be interpreted as exploratory. Overall, the concordant pattern observed across both continuous and categorical outcomes supports the interpretation that adding rTAS, directed to a scalp region involved in cognitive-affective regulation, to PNEA enhances both ejaculatory control and mood symptoms, while remaining a clinically feasible and well-tolerated neuromodulatory strategy for men with PE.

Anatomically, the pudendal nerve arises from S2–S4 and conveys sensory input from the external genitalia to the central nervous system, primarily via the dorsal penile nerve, thereby serving as a key peripheral substrate for ejaculatory control. Stimulation delivered through PNEA may induce neural activation along this pathway and, with repeated sessions, increase tolerance to sexual stimulation, thereby contributing to delayed ejaculation. In addition, electrical stimulation may enhance local perfusion and promote the release of vasoactive mediators [10]. Previous studies have reported favorable outcomes of pudendal nerve electrical stimulation in stress urinary incontinence, possibly through the induction of rhythmic pelvic floor contractions and strengthening of pelvic floor musculature [11, 12]. Given that many patients with PE exhibit pelvic floor muscle weakness, we extended this approach to men with PE [13], and the outcomes observed in the control group of the present study further support the therapeutic value of PNEA in this setting; however, PNEA alone did not sufficiently alleviate depressive symptoms, highlighting the need for adjunctive strategies that target central affective regulation.

Given the close links between PE, central nervous system function, and psychological status, we combined rTAS with PNEA in this study. rTAS stimulates scalp projections of cortical functional regions and uses high-frequency twirling to achieve sufficient stimulus intensity, enabling the signal to traverse the skull and act on corresponding cortical areas to modulate brain function. To our knowledge, this technique has not previously been applied in the field of andrology. We targeted the cognitive-affective area, which approximately corresponds to the prefrontal pole and plays a critical role in the regulation of mental state, cognition, and emotion; prefrontal involvement in ejaculatory control has also been reported [14]. In the present study, SAS and SDS scores declined significantly after treatment in the observation group, accompanied by greater improvement in PE symptoms than in the control group, thereby supporting the potential utility of rTAS as an adjunctive neuromodulatory approach for PE.

rTAS represents a form of brain neuromodulation. Among established non-invasive neuromodulatory techniques, repetitive transcranial magnetic stimulation (rTMS) modifies cortical excitability by delivering rapidly changing magnetic fields via scalp-mounted coils, with the induced electromagnetic fields penetrating the skull and acting directly on the cerebral cortex. rTMS has demonstrated promise in various neurological and psychiatric disorders, and has even been reported to improve anejaculation [15]. rTAS shares this transcranial regulatory principle but differs in that it utilizes acupuncture needles inserted into the scalp and driven by high-frequency twirling, a mode of stimulation that may enhance energy transmission across the skull and thereby augment modulation of cortical targets and clinical efficacy.

During rTAS sessions, most patients reported a localized scalp deqi sensation, an indicator in Traditional Chinese Medicine that adequate needling stimulation has been achieved. This sensation typically subsided shortly after the session and was frequently followed by a sense of relaxation or comfort, a pattern that aligns with the expected neuromodulatory effects of transcranial acupuncture stimulation.

Mechanistically, the rationale for combining PNEA with rTAS lies in achieving a “dual-pathway synergy” that simultaneously engages peripheral and central regulatory mechanisms. Ejaculation is coordinated by a spinal “ejaculatory generator” in the lumbosacral cord, which integrates afferent input from the pudendal nerve with descending signals from cortical and subcortical structures [16]. As discussed above, PNEA primarily modulates pudendal afferent input and lumbosacral spinal reflex circuits, whereas rTAS predominantly targets central neural networks. Rather than acting in isolation, these two modalities intervene along the same ejaculatory control axis, concurrently activating bottom-up peripheral reflex pathways and top-down supraspinal regulatory circuits. Comparable “peripheral + central” neuromodulation paradigms have been investigated in other disease contexts, for example, post-stroke motor rehabilitation and sports medicine, where combining rTMS with repetitive peripheral magnetic stimulation or peripheral nerve electrical stimulation has been reported to enhance neuroplasticity and promote functional recovery by co-recruiting peripheral and central mechanisms [17]. Taken together, this integrated peripheral–central framework provides a plausible mechanistic explanation for the combined regimen in the present study, which produced greater improvements in IELT and mood symptoms than PNEA alone.

Safety was also assessed in this study. Both groups experienced adverse events, all of which were mild and self-limited. Minor bleeding at the needle site was the most frequently observed event and resolved within 1–3 minutes of sterile compression. In the observation group, two participants reported transient dizziness following scalp needling; symptoms subsided after a short period of rest and did not require further intervention. No serious adverse events occurred in either group, indicating that both PNEA alone and the combined PNEA + rTAS regimen were well tolerated and demonstrated a favorable safety profile [18].

In the setting of an integrative traditional Chinese and Western medicine hospital, many men with PE express a high level of confidence in acupuncture-based interventions. Some patients in our cohort had previously attempted pharmacological treatments but with limited benefit or recurrence of symptoms after discontinuation, further reinforcing their willingness to pursue non-pharmacologic neuromodulatory options. Although PNEA and rTAS are procedurally more invasive than oral pharmacotherapy, they are locally acting, minimally invasive, and reversible neuromodulatory interventions, which may account for the mild and transient adverse events. In addition to the well-recognized side-effect profile of SSRIs, a clinical study suggested that a three-month course of sertraline for PE may adversely affect semen quality [19], which is of particular concerning for younger men wishing to preserve fertility. For patients apprehensive about the potential long-term adverse effects of medication, non-pharmacologic neuromodulatory treatments such as PNEA and rTAS may represent an acceptable and attractive alternative. Compared with standard pharmacological therapy and behavioral interventions, whose effectiveness often depends on sustained motivation and close partner cooperation, the combined PNEA + rTAS regimen offers a non-pharmacologic approach that simultaneously targets peripheral ejaculatory reflex pathways and central affective regulation. This strategy is not intended to supplant guideline-recommended pharmacotherapy but rather to provide an additional treatment option for individuals who decline medication or are unsuitable candidates for long-term drug therapy. However, future head-to-head comparative trials against standard treatments are warranted to further clarify its role in clinical practice.

In summary, this study demonstrates that PNEA combined with rTAS can effectively treat PE while also improving anxiety and depressive symptoms, thereby providing a novel nonpharmacologic treatment option. Nonetheless, several limitations should be acknowledged. First, this was a single-center study with a relatively small sample size, which may affect the precision, generalizability, and reliability of the findings. Second, IELT was measured by patients’ partners using a stopwatch during intercourse; although this approach reflects real-world clinical practice, it is susceptible to measurement error and expectation bias. In addition, the trial was not blinded with respect to participants or treating acupuncturists, as the two acupuncture protocols differed visibly in needle locations and stimulation procedures, which may have introduced expectancy or performance bias, particularly for subjective outcomes. Third, the trial did not include a sham acupuncture control, and most outcomes relied on patient-reported scales; therefore, future studies should incorporate sham-controlled designs and more objective neurophysiological or imaging measures (e.g., fMRI) [20]. Lastly, follow-up was limited to 8 weeks, so the durability of benefits remains unknown, and larger multicenter trials with longer follow-up are warranted.

5. Conclusions

Compared with PNEA alone, PNEA combined with rTAS demonstrated greater efficacy in prolonging intravaginal ejaculatory latency time and in alleviating PE-related symptoms and affective distress. Taken together, these findings indicate that this combined neuromodulatory regimen is a promising and clinically feasible option, which warrants confirmation in larger, adequately powered trials.

Availability of data and materials

The data are contained within this article.

Author contributions

JG and HZ—designed the research study. TZ—performed the treatment. YL and HH—analyzed the data. YD—interpreted the results. JG—drafted the manuscript. All authors contributed to editorial revisions in the manuscript. All authors read and approved the final manuscript.

Ethics approval and consent to participate

This study was conducted with approval from the Ethics Committee of the Second Affiliated Hospital of Zhejiang Chinese Medical University (approval no.: Ethics Review 2025 research No. 020-IH01). Written informed consent was obtained from all participants before their inclusion in the study. Additionally, written informed consent for publication of the clinical images in this journal was obtained from the patient.

Acknowledgment

We thank the clinical staff of the Department of Urology, Second Affiliated Hospital of Zhejiang Chinese Medical University, for their support with participant recruitment, treatment delivery, and data collection. We also appreciate the constructive input from our clinical colleagues on analysis planning and interpretation. Administrative support from the hospital’s research office is gratefully acknowledged.

Funding

This work and related studies were supported by the Natural Science Foundation of Zhejiang Province (grant No. LY20H270003) and the Zhejiang Traditional Chinese Medicine Administration (grant No. 2022ZZ017).

Conflict of interest

The authors declare no conflict of interest.

Supplementary material

Supplementary material associated with this article can be found, in the online version, at https://files.intandro.com/files/article/2038516832443219968/attachment/Supplementary%20material.docx.