Evaluating TENS therapy for premature ejaculation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pelvic floor therapies for lifelong premature ejaculation

  This study tests three pelvic floor treatments (electromagnetic stimulation, biofeedback-assisted training, and standard training) to see which helps men with lifelong premature ejaculation last longer during sex.

  Recruiting Tanta University · Tanta, Tanta · NCT07627438

• Exercise for erectile dysfunction and premature ejaculation

  This project tests whether an 8-week, three-times-weekly exercise program helps men aged 25–45 who have erectile dysfunction and premature ejaculation.

  Recruiting Uskudar University · Istanbul · NCT07442396

• KH-001 to increase time to ejaculation in men with lifelong premature ejaculation

  This test tries KH-001, an on-demand sublingual medicine, to see if it lengthens time to ejaculation and reduces distress in men with lifelong premature ejaculation.

  Recruiting Phase 2 Kadence Bio · Botany, New South Wales · NCT07434271

• Registry for men with ejaculatory and orgasmic dysfunction

  This study is creating a national registry to see how well different treatments work for men who have trouble with ejaculation and orgasms.

  Recruiting Charitable Union for the Research and Education of Peyronie's Disease · Orem, Utah · NCT06605469

• Pelvic floor therapy for erectile dysfunction and premature ejaculation

  This study is testing if pelvic floor therapy can help men with erectile dysfunction and premature ejaculation feel better after 12 weeks of treatment.

  Recruiting Boston Medical Group · Bogotá, Cundinamarca · NCT06425211

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.