Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

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

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).

Study Overview

• Status: Recruiting
• Conditions: Premature Ejaculation
• Intervention / Treatment: Other: Transcutaneous posterior tibial nerve stimulation; Drug: Paroxetine

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolina Sandoval, MSc; Phone Number: +573133920816; Email: csandoval@bostonmedical.com.co
• Study Contact Backup: Name: Héctor Corredor, Md; Phone Number: +573174317162; Email: hcorredor@bostonmedical.com.co

Study Locations

• Colombia
  • Bogotá, Colombia, 110111
    • Recruiting
    • Boston Medical Group
    • Contact: Carolina Sandoval, MSc; Phone Number: +573133920816; Email: csandoval@bostonmedical.com.co
    • Contact: Héctor Corredor, Md; Phone Number: +573174317162; Email: hcorredor@bostonmedical.com.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Boston Medical Group
• Investigators: Principal Investigator: Héctor Corredor, Md, Boston Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 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; Premature Birth; Premature Ejaculation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Selective Serotonin Reuptake Inhibitors; Paroxetine
• Other Study ID Numbers: BMGC-5

Drug and device information, study documents

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