Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Launched by BOSTON MEDICAL GROUP · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called TENS therapy, which involves using electrical stimulation on a nerve in the leg, to see if it can help men with premature ejaculation. Premature ejaculation is when a man ejaculates (or reaches climax) very quickly during sexual activity, often within the first minute, which can lead to stress and frustration. The trial will compare the effects of TENS therapy alone, TENS therapy combined with a standard medication (dapoxetine), and the standard medication alone to find out which option works best.

To be eligible for this study, participants must be men aged 18 to 62 who have been diagnosed with lifelong premature ejaculation and have had this issue for at least six months. They should also be in a stable relationship and have sexual activity at least once a week. Participants will be randomly assigned to one of the three treatment groups and can expect to attend treatment sessions where they will receive either TENS therapy or the standard medication. The trial is currently recruiting participants, and those interested should ensure they meet the eligibility criteria before signing up.

Gender

MALE

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.

Trial Officials