Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Last updated: February 3, 2025
Sponsor: Boston Medical Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Premature Ejaculation

Treatment

Paroxetine

Transcutaneous posterior tibial nerve stimulation

Clinical Study ID

NCT04207723
BMGC-5
  • Ages 18-80
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary premature ejaculation as defined by the International Society for SexualMedicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculationoccurs always or almost always within the first minute after penetration, b)disability to delay ejaculation in all or almost all penetrations, c) negativepersonal 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 ofmaintaining 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

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-traumaticstress, psychiatric disorder, referred by the patient or by the use of a medicationfor one of these terms.

  • Consumption of medications that affect ejaculatory control such as psychiatricmedications, 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.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Paroxetine
Phase:
Study Start date:
July 15, 2020
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Boston Medical Group

    Bogotá, 110111
    Colombia

    Active - Recruiting

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