Effectiveness and Safety of TENS Therapy for Premature Ejaculation (TENSPE2)

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial

The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:

Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?

Patients will:

Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.

Be assigned by randomization to one of three treatment groups:

• Group 1: Tens therapy + dapoxetine placebo on demand.
• Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
• Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).

Study Overview

• Status: Recruiting
• Conditions: Premature Ejaculation; TEN; Sex Disorder
• Intervention / Treatment: Device: Tens therapy; Drug: Dapoxetine placebo; Drug: Standard treatment (dapoxetine 30 mg as needed); Device: Placebo therapy

• Study Type: Interventional
• Enrollment (Estimated): 129
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Mexico
  • Ciudad de México, Mexico, 01000
    • 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: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
• Age between 18 and 62 years.
• PEDT score greater than 11.
• Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
• Sexual activity at least once a week.
• Minimum chronicity of PD of 6 months.
• Voluntary participation in the study.
• Signing of the informed consent prior to participation in the study.

Exclusion Criteria:

• IIEF-EF score less than 26.
• Glaucoma
• Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
• 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 disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
• Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
• Treatment for PE in the last 3 months.
• Treatment for epileptic syndromes or Parkinson's disease.
• Use of pacemaker or cardiac defibrillator.
• Skin lesions in the area where the electrodes are placed.
• Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
• Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.

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
Active Comparator: Group 1: Tens therapy + dapoxetine placebo on demand.; There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.	Device: Tens therapy; There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode (anode - black) is attached to the calcaneus. The equipment must previously be programmed under the following parameters: Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.; Drug: Dapoxetine placebo; Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Active Comparator: Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.; Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.	Drug: Standard treatment (dapoxetine 30 mg as needed); Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study; Device: Placebo therapy; In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
Experimental: Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).; Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.	Device: Tens therapy; There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode (anode - black) is attached to the calcaneus. The equipment must previously be programmed under the following parameters: Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.; Drug: Standard treatment (dapoxetine 30 mg as needed); Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intravaginal latency time	Average change in intravaginal latency time, measured with a stopwatch by the couple.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intravaginal latency time	Average change in intravaginal latency time, measured with a stopwatch by the couple.	24 weeks
Clinical improvement in premature ejaculation	Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.	At weeks 12 (end of therapy) and 24 (three months of follow-up).
Change in the diagnosis of premature ejaculation	Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups	At weeks 12 and 24 (greater than 12 to less than 12).
Global Impression of Change Scale	Global Impression of Change Scale score	Weeks 12 and 24.
PEP (Premature Ejaculation Profile) questionnaire score	Change in the PEP (Premature Ejaculation Profile) questionnaire score	At weeks 12 and 24
Adverse events	Type, frequency and severity of adverse events during therapy.	24 weeks

Collaborators and Investigators

• Sponsor: Boston Medical Group
• Investigators: Principal Investigator: Jorge Barba, MD, Boston Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Ejaculatory Dysfunction; Premature Birth; Premature Ejaculation; Sexual Dysfunction, Physiological
• Other Study ID Numbers: BMGC-M1

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: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes