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NCT Number: NCT06425224

Effectiveness and Safety of TENS Therapy for Premature Ejaculation

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).

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Key information

Conditions

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

Age range

18 year–62 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/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 maintaining it 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 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-traumatic stress disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
  • Consumption of medications that affect ejaculatory control such as psychiatric medications, 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 3 months.

Treatment and study plan

Tens therapy

Device

There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:

  • The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.

The second reference electrode (anode - black) is attached to the calcaneus.

The equipment must previously be programmed under the following parameters:

Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.

Dapoxetine placebo

Drug

Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.

Standard treatment (dapoxetine 30 mg as needed)

Drug

Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study

Placebo therapy

Device

In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.

Primary outcomes

  1. Change in intravaginal latency time

    Time frame: 12 weeks

    Average change in intravaginal latency time, measured with a stopwatch by the couple.

Secondary outcomes

  1. Change in intravaginal latency time

    Time frame: 24 weeks

    Average change in intravaginal latency time, measured with a stopwatch by the couple.

  2. Clinical improvement in premature ejaculation

    Time frame: At weeks 12 (end of therapy) and 24 (three months of follow-up).

    Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.

  3. Change in the diagnosis of premature ejaculation

    Time frame: At weeks 12 and 24 (greater than 12 to less than 12).

    Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups

  4. Global Impression of Change Scale

    Time frame: Weeks 12 and 24.

    Global Impression of Change Scale score

  5. PEP (Premature Ejaculation Profile) questionnaire score

    Time frame: At weeks 12 and 24

    Change in the PEP (Premature Ejaculation Profile) questionnaire score

  6. Adverse events

    Time frame: 24 weeks

    Type, frequency and severity of adverse events during therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Sandoval, Master

CONTACT

[email protected]

+573133920816

Héctor Corredor, MD

CONTACT

[email protected]

+573174317162

Sponsors and collaborators

Lead sponsor

Boston Medical Group

Industry

Registry information

Official study title

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial

Acronym: TENSPE2

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
May 22, 2024

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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