Effectiveness and Safety of TENS Therapy for Premature Ejaculation

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

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.

Sponsors & Collaborators

• Boston Medical Group

  lead INDUSTRY

Principal Investigators

• Jorge Barba, MD · Boston Medical Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

62 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-15

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Drug

Yes

FDA Device

Yes

Countries

• Mexico

Study Locations