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The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
Patients will:
Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.
Be assigned by randomization to one of three treatment groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Tens therapy + dapoxetine placebo on demand. | Active Comparator | There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. |
|
| Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. | Active Comparator | Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. |
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| Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). | Experimental | Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tens therapy | Device | There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode (anode - black) is attached to the calcaneus. The equipment must previously be programmed under the following parameters: Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intravaginal latency time | Average change in intravaginal latency time, measured with a stopwatch by the couple. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intravaginal latency time | Average change in intravaginal latency time, measured with a stopwatch by the couple. | 24 weeks |
| Clinical improvement in premature ejaculation | Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Sandoval, Master | Contact | +573133920816 | csandoval@bostonmedical.com.co | |
| Héctor Corredor, MD | Contact | +573174317162 | hcorredor@bostonmedical.com.co |
| Name | Affiliation | Role |
|---|---|---|
| Jorge Barba, MD | Boston Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Group | Recruiting | Mexico City | 01000 | Mexico |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2026 | Jun 3, 2026 | 1 |
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C080598 | dapoxetine |
| D006301 | Health Services Needs and Demand |
| ID | Term |
|---|---|
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
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| Dapoxetine placebo | Drug | Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. |
|
| Standard treatment (dapoxetine 30 mg as needed) | Drug | Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study |
|
| Placebo therapy | Device | In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. |
|
| At weeks 12 (end of therapy) and 24 (three months of follow-up). |
| Change in the diagnosis of premature ejaculation | Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups | At weeks 12 and 24 (greater than 12 to less than 12). |
| Global Impression of Change Scale | Global Impression of Change Scale score | Weeks 12 and 24. |
| PEP (Premature Ejaculation Profile) questionnaire score | Change in the PEP (Premature Ejaculation Profile) questionnaire score | At weeks 12 and 24 |
| Adverse events | Type, frequency and severity of adverse events during therapy. | 24 weeks |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D017530 | Health Care Quality, Access, and Evaluation |