TPTNS for Treating Patients With Premature Ejaculation

NCT03204890 | Completed Results

• 1 other identifier: BMGC-2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the Basal PDET Score

  Three months after completion.

• Magnitude of the Change in the PEDT Score

  Three months after completion.

• Frequency of Adverse Events

  up to 6 months

Study Arms (1)

TPTNS

EXPERIMENTAL

Transcutaneous Posterior Tibial Nerve Stimulation

Other: Transcutaneous Posterior Tibial Nerve Stimulation

Interventions

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.

TPTNS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Group: lead

Study Sites (1)

Boston Medical Group Colombia

Bogotá, Cundinamarca, 11022, Colombia

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. José Pablo Saffon
• Organization: Boston Medical Group

jsaffon@bostonmedical.com.co

+573208899777

Study Officials

• José P Saffon, Doctor

  Boston Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: June 14, 2017
• Primary Completion: January 15, 2018
• Study Completion: October 30, 2018
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)