Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

NCT ID: NCT04207723

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2026-06-30

Brief Summary

Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.

Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:

• Group 1: Tens + placebo drug therapy
• Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
• Group 3: Tens therapy + standard treatment (paroxetine mg)

The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).

Conditions

Premature Ejaculation

Study Design

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

Study Groups

TENS Therapy

Tens therapy + placebo drug therapy

Group Type: EXPERIMENTAL

Transcutaneous posterior tibial nerve stimulation

Intervention Type: OTHER

Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.

Control

Standard treatment (paroxetine 20 mg) + sham therapy

Group Type: SHAM_COMPARATOR

Paroxetine

Intervention Type: DRUG

paroxetine 20 mg / day taken in the morning hours, per 12 weeks.

Combination therapy

Tens therapy + standard treatment (paroxetine 20 mg)

Group Type: EXPERIMENTAL

Transcutaneous posterior tibial nerve stimulation

Intervention Type: OTHER

Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.

Paroxetine

Intervention Type: DRUG

paroxetine 20 mg / day taken in the morning hours, per 12 weeks.

Interventions

Transcutaneous posterior tibial nerve stimulation

Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.

Intervention Type: OTHER

Paroxetine

paroxetine 20 mg / day taken in the morning hours, per 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
• Age equal to or greater than 18 years.
• PEDT score greater than 11.
• Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
• Sexual activity at least once a week.
• Minimum chronicity of PE of 6 months.
• Voluntary participation in the study.
• Signature of informed consent prior to participation in the study.

Exclusion Criteria

• IIEF-EF score greater than 25.
• Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
• 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, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
• Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
• Treatment for PD in the last 3 months.
• Treatment for epileptic syndromes or Parkinson's disease.
• Use of pacemaker or cardiac defibrillator.
• Skin lesions in the electrode placement area.
• Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
• Couple in a state of pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Héctor Corredor, Md

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Group

Locations

Boston Medical Group

Bogotá, Bogota D.C., Colombia

Site Status: RECRUITING

Countries

Colombia

Central Contacts

Carolina Sandoval, MSc

Role: CONTACT

csandoval@bostonmedical.com.co

+573133920816

Hector 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-5

Identifier Type: -

Identifier Source: org_study_id