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Completed

NCT Number: NCT03204890

TPTNS for Treating Patients With Premature Ejaculation

Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are anatomically and physio-pathologically similar. Based on this, the use of this therapy is considered to be viable for the control of PE.

Objective: To evaluate the efficacy of transcutaneous posterior tibial nerve electrostimulation for the ejaculatory reflex.

Patients and Methods: Phase II clinical trial. Patients with a diagnosis of premature ejaculation who are treated at the Colombia Boston Medical Group clinic will be included. The participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per week for 12 weeks. The IELT (Intravaginal ejaculatory latency time) and the PEDT (Premature Ejaculatory Diagnosis Tool) scale will be evaluated on week 6, at the end of treatment, and three months after completing the protocol.

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Group Colombia

Bogotá, Cundinamarca, 11022, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age and less than 50 years of age with no cardiovascular risk factor other than age.
  • Having been diagnosed with primary premature ejaculation according to the American Psychiatric Society's Diagnostic and Statistical Manual.
  • Agreeing to participate and providing signed informed consent.
  • Stable relationship for over 6 months, with frequent intercourse at least once per week.

Exclusion criteria

  • Diagnosis of erectile dysfunction according to the International Index Function Erectile (IIFE-5) (score under 21).
  • A premature ejaculatory diagnosis tool (PEDT) score under 8.
  • Use of treatment for premature ejaculation during the study or over the 6 months prior to beginning the study.
  • Use of pacemaker or heart defibrillator.
  • Epilepsy or convulsions
  • Venous insufficiency (varices) or cutaneous wounds or injuries on the lower extremities.
  • Congenital or acquired anatomical abnormalities of the penis.
  • Taking medications that affect ejaculation control, including psychiatric medications, opioid analgesics, and medications for pathologies of the prostate such as alpha-blockers.
  • Psychological or psychiatric disorders that prevent the patient from undergoing the treatment or recording the measurements as established.
  • Difficulty going to the clinic 3 times per week as required by the protocol.
  • Patients with pre-coital premature ejaculation.
  • Use of barrier contraceptive methods or local anesthetics.

Treatment and study plan

Transcutaneous posterior tibial nerve stimulation

Other

Three (3) sessions per week for twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual. In each session, it is normal to have plantar flexion of the foot and flexion of the first toe, and after the session and particularly during the first sessions there is the possibility of muscle pain, which should be tolerable.

Primary outcomes

  1. Clinical Improvement

    Time frame: Three months after completion.

    Number of patients with clinical improvement of premature ejaculation, defined as a tripling of the baseline time (without treatment), as measured by the IELT (intravaginal ejaculation latency time)

Secondary outcomes

  1. Change in the Basal PDET Score

    Time frame: Three months after completion.

    The premature ejaculation diagnostic tool (PEDT), is a questionnaire for the diagnosis of premature ejaculation. The questionnaire has 5 questions and each of them scores from 0 to 4. The score is the sum of all the answers (range 0-20), with higher scores suggesting more difficulties with premature ejaculation. A score ≥11 points suggested the presence of premature ejaculation. This outcome indicates the number of patients who decrease their initial PEDT score after 3 months after completing treatment.

  2. Magnitude of the Change in the PEDT Score

    Time frame: Three months after completion.

    The premature ejaculation diagnostic tool (PEDT), is a questionnaire for the diagnosis of premature ejaculation. The questionnaire has 5 questions and each of them scores from 0 to 4. The score is the sum of all the answers (range 0-20), with higher scores suggesting more difficulties with premature ejaculation. A score ≥11 points suggested the presence of premature ejaculation. This outcome indicates the average change that patients had in their PEDT score at baseline, 3 months after completing treatment.

  3. Frequency of Adverse Events

    Time frame: up to 6 months

    Number of patients with adverse events or side effects with the therapy

Sponsors and collaborators

Lead sponsor

Boston Medical Group

Industry

Registry information

Official study title

Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2017
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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