Comparison of the Efficacy and Safety of Dapoxetine, Kegel Exercises, and Acupuncture in the Treatment of Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Trial

Study OverviewPremature ejaculation (PE) is one of the most prevalent male sexual dysfunctions, affecting approximately 20-30% of men worldwide. It is defined by the International Society of Sexual Medicine (ISSM) as ejaculation occurring within one minute of vaginal penetration, accompanied by a lack of control over ejaculation and resultant distress or interpersonal difficulties (Althof et al., 2014). PE significantly impacts quality of life, self-esteem, and relationship satisfaction. Current treatment options include pharmacological interventions (e.g., dapoxetine, a selective serotonin reuptake inhibitor), behavioral therapies (e.g., Kegel exercises targeting pelvic floor muscles), and complementary approaches (e.g., acupuncture). However, there is a lack of comprehensive studies comparing the efficacy and safety of these interventions in a single trial. This study aims to address this gap by evaluating the efficacy and safety of dapoxetine, Kegel exercises, acupuncture, and their respective placebo controls in a randomized, double-blind, placebo-controlled trial.Study ObjectivesThe primary objective is to compare the efficacy of dapoxetine, Kegel exercises, and acupuncture in increasing intravaginal ejaculation latency time (IELT) in men with PE, relative to placebo and sham controls. Secondary objectives include assessing improvements in PE severity, sexual quality of life, and the safety profile of each intervention. The study hypothesizes that:Dapoxetine, Kegel exercises, and acupuncture will significantly increase IELT compared to their respective placebo/sham groups.

Differences in efficacy will be observed among the active treatment groups. All interventions will demonstrate acceptable safety profiles with minimal adverse effects.

Study DesignThis is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 250 male participants will be enrolled and randomly assigned to one of five groups (50 participants per group) in a 1:1:1:1:1 ratio. The study duration is 24 months, including 6 months for preparation and recruitment, 12 months for intervention and data collection, and 6 months for data analysis and dissemination. The intervention phase lasts 12 weeks, followed by a 4-week follow-up period to assess sustained effects.Randomization and Blinding:Randomization will be performed using a computer-generated random number sequence to ensure balanced allocation across groups.

Double-blinding will be maintained by ensuring that participants and outcome assessors are unaware of group assignments. Dapoxetine and placebo tablets will be identical in appearance and packaging. Acupuncture and sham acupuncture procedures will use standardized needles to maintain blinding, with sham acupuncture involving superficial needle insertion at non-active points.

Study PopulationThe study will recruit 250 men aged 18-50 years diagnosed with PE according to ISSM criteria. Participants will be enrolled from university hospitals and private clinics across multiple centers (specific sites to be determined).Inclusion Criteria:Male, aged 18-50 years.