Menu
Recruiting NCT06425224

Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Phase III Interventional Premature Ejaculation Sex Disorder TEN

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tens therapy, Dapoxetine placebo, Standard treatment (dapoxetine 30 mg as needed), Placebo therapy.
Who it may be relevant to
Registry conditions: Premature Ejaculation, Sex Disorder, TEN. Basic parameters: 18 years — 62 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Device Tens therapy
    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: 1\. 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.
  • Drug Dapoxetine placebo
    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.
  • Drug Standard treatment (dapoxetine 30 mg as needed)
    Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study
  • Device Placebo therapy
    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 outcome measures

  • Change in intravaginal latency time [Time frame: 12 weeks]
Secondary outcome measures (6)
  • Change in intravaginal latency time [Time frame: 24 weeks]
  • Clinical improvement in premature ejaculation [Time frame: At weeks 12 (end of therapy) and 24 (three months of follow-up).]
  • Change in the diagnosis of premature ejaculation [Time frame: At weeks 12 and 24 (greater than 12 to less than 12).]
  • Global Impression of Change Scale [Time frame: Weeks 12 and 24.]
  • PEP (Premature Ejaculation Profile) questionnaire score [Time frame: At weeks 12 and 24]
  • Adverse events [Time frame: 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Boston Medical Group — Mexico City

Identifiers

NCT: NCT06425224 · BMGC-M1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗