drugset / Trial / NCT04207723

Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

NCT04207723

Completed 120 enrolled Boston Medical Group
RandomizedParallel-groupTriple-blindTreatment

Summary

Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment. Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups: * Group 1: Tens + placebo drug therapy * Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy * Group 3: Tens therapy + standard treatment (paroxetine mg) The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).

Timeline

Start
2020-07-15
Primary completion
2026-01-09
Completion
2026-04-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Paroxetine Small molecule 20 mg

Indications