Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment. Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups: Group 1: Tens + placebo drug therapy Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy Group 3: Tens therapy + standard treatment (paroxetine mg) The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).

Official Title
-----------------
Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment

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

Intervention / Treatment
-----------------
* Other: Transcutaneous posterior tibial nerve stimulation
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy. Age equal to or greater than 18 years. PEDT score greater than 11. Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study. Sexual activity at least once a week. Minimum chronicity of PE of 6 months. Voluntary participation in the study. Signature of informed consent prior to participation in the study. Exclusion Criteria: IIEF-EF score greater than 25. Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic. 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, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms. Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers. Treatment for PD in the last 3 months. Treatment for epileptic syndromes or Parkinson's disease. Use of pacemaker or cardiac defibrillator. Skin lesions in the electrode placement area. Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs. Couple in a state of pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS Therapy<br>Tens therapy + placebo drug therapy | Other: Transcutaneous posterior tibial nerve stimulation<br>* Three (3) sessions per week per 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.<br>|
| Sham Comparator: Control<br>Standard treatment (paroxetine 20 mg) + sham therapy | Drug: Paroxetine<br>* paroxetine 20 mg / day taken in the morning hours, per 12 weeks.<br>|
| Experimental: Combination therapy<br>Tens therapy + standard treatment (paroxetine 20 mg) | Other: Transcutaneous posterior tibial nerve stimulation<br>* Three (3) sessions per week per 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.<br>Drug: Paroxetine<br>* paroxetine 20 mg / day taken in the morning hours, per 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravaginal latency time at week 12 | Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score | Patients with a change in Premature Ejaculation Diagnostic Tool questionnaire score at weeks 12 and 24. A score of 11 or more suggests PE. A score of 9 or 10 may be found in men with PE; it is a borderline score. A score of 8 or less suggests that a man does not have PE. The minimum and maximum values are 0 and 20, respectively. | weeks 12 and 24 | 
| Clinical improvement | Three-fold increase in intravaginal ejaculatory latency time | weeks 12 and 24 |