TPTNS for Treating Patients With Premature Ejaculation

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Other: Transcutaneous Posterior Tibial Nerve Stimulation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 11022
      • Boston Medical Group Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TPTNS; Transcutaneous Posterior Tibial Nerve Stimulation

Other: Transcutaneous Posterior Tibial Nerve Stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement	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)	Three months after completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Basal PDET Score	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.	Three months after completion.
Magnitude of the Change in the PEDT Score	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.	Three months after completion.
Frequency of Adverse Events	Number of patients with adverse events or side effects with the therapy	up to 6 months

Collaborators and Investigators

• Sponsor: Boston Medical Group
• Investigators: Principal Investigator: José P Saffon, Doctor, Boston Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Ejaculatory Dysfunction; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: BMGC-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No