Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Last updated: May 17, 2024
Sponsor: Boston Medical Group
Overall Status: Active - Recruiting

Phase

3

Condition

Premature Ejaculation

Sexual Dysfunction

Treatment

Standard treatment (dapoxetine 30 mg as needed)

Placebo therapy

Tens therapy

Clinical Study ID

NCT06425224
BMGC-M1
  • Ages 18-62
  • Male

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary premature ejaculation according to the definition of the InternationalSociety for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30):a) ejaculation always or almost always occurs within the first minute afterpenetration, b) inability to delay ejaculation in all or almost all penetrations, c)negative personal consequences are generated, such as stress, annoyance, frustrationand/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 maintainingit 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

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-traumaticstress disorder, psychiatric disorder, reported by the patient or due to the use ofa medication for one of these conditions.

  • Consumption of medications that affect ejaculatory control such as psychiatricmedications, 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 3months.

Study Design

Total Participants: 129
Treatment Group(s): 4
Primary Treatment: Standard treatment (dapoxetine 30 mg as needed)
Phase: 3
Study Start date:
June 15, 2022
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Boston Medical Group

    Ciudad de México, 01000
    Mexico

    Active - Recruiting

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