Status:

RECRUITING

Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Lead Sponsor:

Boston Medical Group

Conditions:

Premature Ejaculation

Sex Disorder

Eligibility:

MALE

18-62 years

Phase:

PHASE3

Brief Summary

The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question ...

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.

Key Trial Info

Start Date :

June 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2025

Estimated Enrollment :

129 Patients enrolled

Trial Details

Trial ID

NCT06425224

Start Date

June 15 2022

End Date

June 1 2025

Last Update

May 22 2024

Active Locations (1)

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Boston Medical Group

Mexico City, Mexico, 01000