Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Not Applicable

Recruiting

• Conditions: Premature Ejaculation
• Interventions: Other: Transcutaneous posterior tibial nerve stimulation; Drug: Paroxetine

• Registration Number: NCT04207723
• Lead Sponsor: Boston Medical Group

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Study Start: 2020-07-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS Therapy	Transcutaneous posterior tibial nerve stimulation	Tens therapy + placebo drug therapy
Combination therapy	Transcutaneous posterior tibial nerve stimulation	Tens therapy + standard treatment (paroxetine 20 mg)
Control	Paroxetine	Standard treatment (paroxetine 20 mg) + sham therapy
Combination therapy	Paroxetine	Tens therapy + standard treatment (paroxetine 20 mg)

Primary Outcome Measures

Name	Time	Method
Intravaginal latency time at week 12	Week 12	Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.

Secondary Outcome Measures

Name	Time	Method
Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score	weeks 12 and 24	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.
Clinical improvement	weeks 12 and 24	Three-fold increase in intravaginal ejaculatory latency time

Trial Locations

Locations (1)

Boston Medical Group; 🇨🇴 Bogotá, Colombia