TPTNS for Treating Patients With Premature Ejaculation

Study Overview
=================
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 and the PEDT scale will be evaluated on week 6, at the end of treatment and three months after completing the protocol.

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

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Other: Transcutaneous Posterior Tibial Nerve Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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 DSM 5 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 IIFE 5 (score under 21). A 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 precoital premature ejaculation. Use of barrier contraceptive methods or local anesthetics.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPTNS<br>Transcutaneous Posterior Tibial Nerve Stimulation | Other: Transcutaneous Posterior Tibial Nerve Stimulation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Proportion 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 |  | Three months after completion. | 
| Magnitude of the change in the PEDT score |  | Three months after completion. | 
| Frequency and severity of adverse events |  | During the therapy |