This study aims to compare the efficacy and safety of dapoxetine, Kegel exercises, acupuncture, and their placebo controls in the treatment of premature ejaculation (PE). PE is a common male sexual dysfunction characterized by ejaculation occurring within one minute of vaginal penetration, causing distress or interpersonal difficulties (Althof et al., 2014). A total of 250 male participants will be randomized into five groups (dapoxetine, placebo, Kegel exercises, acupuncture, sham acupuncture) for a 12-week treatment period followed by a 4-week follow-up. The primary outcome is the increase in intravaginal ejaculation latency time (IELT), with secondary outcomes including the Premature Ejaculation Diagnostic Tool (PEDT) score, Sexual Quality of Life-Male (SQoL-M) score, and adverse effects.
Male, aged 18-50 years. Diagnosed with lifelong or acquired PE per ISSM criteria (IELT < 2 minutes, lack of ejaculatory control, and associated distress or interpersonal difficulties).
Presence of erectile dysfunction (diagnosed via International Index of Erectile Function score < 21).
Parallel
serotonin reuptake inhibitor (SSRI)
DrugDapoxetine Group Dosage: 30 mg dapoxetine, taken orally 1-3 hours before anticipated sexual activity, with a maximum of 3 doses per week. Administration: Provided in blister packs to ensure compliance. Reference: McMahon et al., 2011.
Placebo
DrugDosage: Placebo tablets identical in appearance and taste to dapoxetine, administered on the same schedule (1-3 hours before sexual activity, maximum 3 doses per week). Administration: Provided in identical blister packs.
Acupuncture
Other interventionProtocol: Two 30-minute acupuncture sessions per week, targeting standardized points (e.g., CV4, SP6, ST36) known to influence sexual function and autonomic nervous system regulation. Administration: Performed by licensed acupuncturists following a standardized protocol. Reference: Sunay et al., 2011.
Sham
Other interventionSham Acupuncture Group:Protocol: Two 30-minute sessions per week using superficial needle insertion at non-active points to minimize therapeutic effects while maintaining the placebo effect. Administration: Performed by licensed acupuncturists to ensure consistency with the active acupuncture group
Exercise
BehavioralKegel Exercises Group:Protocol: Participants will perform pelvic floor muscle exercises consisting of three sets of 10-15 contractions daily, each held for 5-10 seconds followed by relaxation. Training: Participants will receive initial training from a licensed physiotherapist, with weekly follow-up sessions to ensure proper technique and adherence. Reference: Pastore et al., 2014.
Intravaginal Ejaculation Latency Time (IELT):
Measured by stopwatch during sexual intercourse, reported as the weekly average. Participants will record IELT for each sexual encounter.
Premature Ejaculation Diagnostic Tool (PEDT):
A validated 5-item questionnaire assessing PE severity, including control, frequency, and distress (Symonds et al., 2007).
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