NCT04207723

Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Boston Medical Group · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
OTHER	Transcutaneous posterior tibial nerve stimulation	Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.
DRUG	Paroxetine	paroxetine 20 mg / day taken in the morning hours, per 12 weeks.

Timeline

• Start date: 2020-07-15
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2019-12-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Colombia