NCT06425224

Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Boston Medical Group · Industry
• Sex: Male
• Age: 18 Years – 62 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Premature Ejaculation
• Sex Disorder
• TEN

Interventions

Type	Name	Description
DEVICE	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.
DRUG	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.
DRUG	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
DEVICE	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.

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-05-22
• Last updated: 2024-05-22

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study
• FDA-regulated device study