Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Launched by BOSTON MEDICAL GROUP · Dec 19, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for men who experience premature ejaculation, a condition where ejaculation happens too quickly during sexual activity. The study will compare the effects of a technique called transcutaneous electrostimulation of the posterior tibial nerve, both on its own and combined with a standard medication called paroxetine, against the medication alone. Men between the ages of 18 and 75 who have been diagnosed with primary premature ejaculation and are in a stable heterosexual relationship may be eligible to participate.

If you join the study, you will be randomly assigned to one of three groups: one will receive the nerve stimulation along with a placebo (a non-active treatment), another will get the standard medication with a placebo, and the last group will receive both the nerve stimulation and the medication. Throughout the trial, you'll be monitored for any changes in how long it takes to ejaculate, as well as your overall satisfaction with your sexual experiences. The trial is currently recruiting participants, and all interested individuals will need to provide informed consent before joining.

Gender

MALE

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.