An interventional study of Transcutaneous posterior tibial nerve stimulation and Paroxetine in Premature Ejaculation, sponsored by Boston Medical Group. Completed at 1 site in Colombia. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Boston Medical Group · Not applicable, Interventional, and Treatment
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:
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).
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 120 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Boston Medical Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tens therapy + placebo drug therapy
Other: Transcutaneous posterior tibial nerve stimulation
Standard treatment (paroxetine 20 mg) + sham therapy
Drug: Paroxetine
Tens therapy + standard treatment (paroxetine 20 mg)
Other: Transcutaneous posterior tibial nerve stimulation · Drug: Paroxetine
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 20 mg / day taken in the morning hours, per 12 weeks.
Intravaginal latency time at week 12
Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.
Time frame: Week 12
Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score
Patients with a change in Premature Ejaculation Diagnostic Tool questionnaire score at weeks 12 and 24. A score of 11 or more suggests PE. A score of 9 or 10 may be found in men with PE; it is a "borderline" score. A score of 8 or less suggests that a man does not have PE. The minimum and maximum values are 0 and 20, respectively.
Time frame: weeks 12 and 24
Clinical improvement
Three-fold increase in intravaginal ejaculatory latency time
Time frame: weeks 12 and 24
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paroxetine
Boston Medical Group