Effectiveness and Safety of TENS Therapy for Premature Ejaculation

PHASE3RecruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

June 15, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Premature EjaculationSex DisorderTEN
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.

Trial Locations (1)

01000

RECRUITING

Boston Medical Group, Mexico City

Sponsors
All Listed Sponsors
lead

Boston Medical Group

INDUSTRY