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Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Study acronym: TENSPE2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 22, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is: Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine? Patients will: Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included. Be assigned by randomization to one of three treatment groups: * Group 1: Tens therapy + dapoxetine placebo on demand. * Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. * Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Trial Details
NCT Number NCT06425224
Lead Sponsor Boston Medical Group
Conditions
(from sponsor)
Premature Ejaculation, Sex Disorder, TEN
Related terms Premature Ejaculation, Sexual Dysfunction, Physiological
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov