MedTrace Logo

Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

NCT04207723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Boston Medical Group

    lead INDUSTRY

Principal Investigators

  • Héctor Corredor, Md · Boston Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Colombia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207723 on ClinicalTrials.gov