Effectiveness and Safety of TENS Therapy for Premature Ejaculation

NCT ID: NCT06425224

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-06-30

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).

Conditions

Premature Ejaculation; Sex Disorder; TEN

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Tens therapy + dapoxetine placebo on demand.

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 Type: ACTIVE_COMPARATOR

Tens therapy

Intervention Type: DEVICE

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 placebo

Intervention Type: DRUG

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.

Group 2: Standard treatment (dapoxetine 30 mg as needed) + 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 Type: ACTIVE_COMPARATOR

Standard treatment (dapoxetine 30 mg as needed)

Intervention Type: 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 therapy

Intervention Type: DEVICE

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 + 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 Type: EXPERIMENTAL

Tens therapy

Intervention Type: DEVICE

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.

Standard treatment (dapoxetine 30 mg as needed)

Intervention Type: 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

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: 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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Barba, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Group

Locations

Boston Medical Group

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Carolina Sandoval, Master

Role: CONTACT

csandoval@bostonmedical.com.co

+573133920816

Héctor Corredor, MD

Role: CONTACT

hcorredor@bostonmedical.com.co

+573174317162

Facility Contacts

Carolina Sandoval, MSc

Role: primary

csandoval@bostonmedical.com.co

+573133920816

Héctor Corredor, Md

Role: backup

hcorredor@bostonmedical.com.co

+573174317162

Other Identifiers

BMGC-M1

Identifier Type: -

Identifier Source: org_study_id