Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Phase 3

Recruiting

• Conditions: TEN; Sex Disorder; Premature Ejaculation
• Interventions: Device: Tens therapy; Drug: Standard treatment (dapoxetine 30 mg as needed); Device: Placebo therapy; Drug: Dapoxetine placebo

• Registration Number: NCT06425224
• Lead Sponsor: Boston Medical Group

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Tens therapy + dapoxetine placebo on demand.	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 is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. 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. They will also 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.
Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.	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. 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.
Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.	Placebo therapy	Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. 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.
Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).	Tens therapy	Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 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. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).	Standard treatment (dapoxetine 30 mg as needed)	Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 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. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Group 1: Tens therapy + dapoxetine placebo on demand.	Dapoxetine placebo	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 is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. 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. They will also 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.

Primary Outcome Measures

Name	Time	Method
Change in intravaginal latency time	12 weeks	Average change in intravaginal latency time, measured with a stopwatch by the couple.

Secondary Outcome Measures

Name	Time	Method
Adverse events	24 weeks	Type, frequency and severity of adverse events during therapy.
Change in the diagnosis of premature ejaculation	At weeks 12 and 24 (greater than 12 to less than 12).	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
Clinical improvement in premature ejaculation	At weeks 12 (end of therapy) and 24 (three months of follow-up).	Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.
Change in intravaginal latency time	24 weeks	Average change in intravaginal latency time, measured with a stopwatch by the couple.
PEP (Premature Ejaculation Profile) questionnaire score	At weeks 12 and 24	Change in the PEP (Premature Ejaculation Profile) questionnaire score
Global Impression of Change Scale	Weeks 12 and 24.	Global Impression of Change Scale score

Trial Locations

Locations (1)

Boston Medical Group; 🇲🇽 Ciudad de México, Mexico