Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation

What this Trial Is About

Researchers are studying the effectiveness and safety of transcutaneous posterior tibial nerve stimulation (TENS) therapy in men with lifelong premature ejaculation. The trial compares TENS therapy alone, standard pharmacological treatment with dapoxetine, and a combination of both treatments. The study aims to answer whether combining these therapies improves outcomes compared to dapoxetine alone in adult men diagnosed with premature ejaculation attending clinics in Mexico City. Participants are randomly assigned to one of three groups: Group 1 receives TENS therapy plus a placebo pill; Group 2 receives dapoxetine 30 mg as needed plus placebo TENS therapy; Group 3 receives both TENS therapy and dapoxetine. The TENS therapy involves three weekly 30-minute sessions for 12 weeks, delivering a 20 Hz electrical current with adjustable intensity based on patient tolerance. Dapoxetine or placebo pills are taken 3 to 4 hours before sexual intercourse during the 12-week intervention. During the study, participants undergo evaluations including changes in intravaginal latency time measured at 12 and 24 weeks, clinical improvement assessments, and questionnaires such as the Premature Ejaculation Profile and Global Impression of Change. Safety is monitored through reported adverse events over 24 weeks. The study lasts at least six months, including a 12-week treatment period and a 12-week follow-up to assess lasting effects.

Effectiveness and Safety of TENS Therapy for Premature Ejaculation