Evaluating TENS therapy for premature ejaculation
Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
PHASE3 · Boston Medical Group · NCT06425224
This study is testing if TENS therapy, alone or with a medication, can help men with lifelong premature ejaculation feel more in control.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 129 (estimated) |
| Ages | 18 Years to 62 Years |
| Sex | Male |
| Sponsor | Boston Medical Group (industry) |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT06425224 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness and safety of transcutaneous posterior tibial nerve stimulation (TENS) therapy in men with lifelong premature ejaculation. Participants will be randomly assigned to one of three treatment groups: TENS therapy combined with a placebo, standard treatment with dapoxetine, or TENS therapy combined with dapoxetine. The study will compare the outcomes of these groups to determine the best approach for managing this condition. The trial will take place at Boston Medical Group clinics in Mexico City.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 62 with a diagnosis of primary premature ejaculation and a stable heterosexual relationship.
Not a fit: Patients with significant comorbidities or those with erectile dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new non-pharmacological treatment option for men suffering from premature ejaculation.
How similar studies have performed: Other studies have explored similar non-pharmacological approaches, but the effectiveness of TENS therapy specifically for premature ejaculation is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City
- Boston Medical Group — Mexico City, Mexico (RECRUITING)
Study contacts
- Principal investigator: Jorge Barba, MD — Boston Medical Group
- Study coordinator: Carolina Sandoval, Master
- Email: csandoval@bostonmedical.com.co
- Phone: +573133920816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Ejaculation, Sex Disorder, TEN