Using nerve stimulation to treat premature ejaculation

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment

This study is testing if a new nerve stimulation treatment can help men with premature ejaculation last longer during sex compared to standard medications or a combination of both.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Boston Medical Group (Industry-sponsored)
• Locations: 1 site (Bogotá)
• Trial ID: NCT04207723 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve in men with primary premature ejaculation. Participants will be randomly assigned to one of three treatment groups: nerve stimulation with placebo, standard pharmacological treatment with placebo, or a combination of both. The study aims to measure changes in intravaginal latency time and other related scales to assess the impact of the treatments. The trial is conducted at Boston Medical Group clinics in Colombia and Spain.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with a diagnosis of primary premature ejaculation and a stable heterosexual relationship.

Not a fit: Patients with significant erectile dysfunction or other serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for men suffering from premature ejaculation, potentially improving their sexual health and relationships.

How similar studies have performed: Other studies have explored nerve stimulation for sexual dysfunction, showing promising results, but this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
* Age equal to or greater than 18 years.
* PEDT score greater than 11.
* Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
* Sexual activity at least once a week.
* Minimum chronicity of PE of 6 months.
* Voluntary participation in the study.
* Signature of informed consent prior to participation in the study.

Exclusion Criteria:

* IIEF-EF score greater than 25.
* Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
* 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, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
* Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
* Treatment for PD in the last 3 months.
* Treatment for epileptic syndromes or Parkinson's disease.
* Use of pacemaker or cardiac defibrillator.
* Skin lesions in the electrode placement area.
* Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
* Couple in a state of pregnancy.

Where this trial is running

Bogotá

• Boston Medical Group — Bogotá, Colombia (Recruiting)

Study contacts

• Principal investigator: Héctor Corredor, Md — Boston Medical Group
• Study coordinator: Carolina Sandoval, MSc

Conditions Premature Ejaculation