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Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation
Sponsor: Boston Medical Group
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).
Official title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
Key Details
Gender
MALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2020-07-15
Completion Date
2026-06
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
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.
Paroxetine
paroxetine 20 mg / day taken in the morning hours, per 12 weeks.
Locations (1)
Boston Medical Group
Bogotá, Bogota D.C., Colombia