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Completed

NCT Number: NCT04207723

Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

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).

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Group

Bogotá, 110111, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

paroxetine

Drug

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

Primary outcomes

  1. Intravaginal latency time at week 12

    Time frame: Week 12

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

Secondary outcomes

  1. Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score

    Time frame: weeks 12 and 24

    Patients with a change in Premature Ejaculation Diagnostic Tool questionnaire score at weeks 12 and 24. A score of 11 or more suggests PE. A score of 9 or 10 may be found in men with PE; it is a "borderline" score. A score of 8 or less suggests that a man does not have PE. The minimum and maximum values are 0 and 20, respectively.

  2. Clinical improvement

    Time frame: weeks 12 and 24

    Three-fold increase in intravaginal ejaculatory latency time

Sponsors and collaborators

Lead sponsor

Boston Medical Group

Industry

Registry information

Official study title

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2019
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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