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Effectiveness and Safety of TENS Therapy for Premature Ejaculation
Sponsor: Boston Medical Group
Summary
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: * Group 1: Tens therapy + dapoxetine placebo on demand. * Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. * Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Official title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
Key Details
Gender
MALE
Age Range
18 Years - 62 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2022-06-15
Completion Date
2025-06
Last Updated
2024-05-22
Healthy Volunteers
No
Conditions
Interventions
Tens therapy
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.
Dapoxetine placebo
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)
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
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.
Locations (1)
Boston Medical Group
Mexico City, Mexico