Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

NCT04207723 | Recruiting

• 1 other identifier: BMGC-5
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intravaginal latency time at week 12

  Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.

  Week 12

Secondary Outcomes (2)

• Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score

  weeks 12 and 24

• Clinical improvement

  weeks 12 and 24

Study Arms (3)

TENS Therapy

EXPERIMENTAL

Tens therapy + placebo drug therapy

Other: Transcutaneous posterior tibial nerve stimulation

Control

SHAM COMPARATOR

Standard treatment (paroxetine 20 mg) + sham therapy

Drug: Paroxetine

Combination therapy

EXPERIMENTAL

Tens therapy + standard treatment (paroxetine 20 mg)

Other: Transcutaneous posterior tibial nerve stimulation; Drug: Paroxetine

Interventions

Transcutaneous posterior tibial nerve stimulation 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.

Combination therapy; TENS Therapy

Paroxetine DRUG

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

Combination therapy; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Group: lead

Study Sites (1)

Boston Medical Group

Bogotá, Bogota D.C., 110111, Colombia

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Héctor Corredor, Md

  Boston Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Sandoval, MSc

CONTACT

+573133920816; csandoval@bostonmedical.com.co

Hector Corredor, Md

CONTACT

+573174317162; hcorredor@bostonmedical.com.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: July 15, 2020
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

CO (1)