Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Phase 3RecruitingNCT06425224

Boston Medical Group129 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

129

Conditions

Premature Ejaculation Sex Disorder TEN

Interventions

Tens therapyDEVICE

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 placeboDRUG

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 therapyDEVICE

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 62 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy. * Age between 18 and 62 years. * PEDT score greater than 11. * Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study. * Sexual activity at least once a week. * Minimum chronicity of PD of 6 months. * Voluntary participation in the study. * Signing of the informed consent prior to participation in the study. Exclusion Criteria: * IIEF-EF score less than 26. * Glaucoma * Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological. * History of retroperitoneal surgery, radiotherapy or multiple sclerosis. * History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions. * Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers. * Treatment for PE in the last 3 months. * Treatment for epileptic syndromes or Parkinson's disease. * Use of pacemaker or cardiac defibrillator. * Skin lesions in the area where the electrodes are placed. * Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs. * Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.

Outcomes

Primary Outcomes

Change in intravaginal latency time

Average change in intravaginal latency time, measured with a stopwatch by the couple.

Time frame: 12 weeks

Secondary Outcomes

Change in intravaginal latency time

Average change in intravaginal latency time, measured with a stopwatch by the couple.

Time frame: 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.

Time frame: 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

Time frame: At weeks 12 and 24 (greater than 12 to less than 12).

Global Impression of Change Scale

Global Impression of Change Scale score

Time frame: Weeks 12 and 24.

PEP (Premature Ejaculation Profile) questionnaire score

Change in the PEP (Premature Ejaculation Profile) questionnaire score

Time frame: At weeks 12 and 24

Adverse events

Type, frequency and severity of adverse events during therapy.