Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207723
• Other study ID #: BMGC-5
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Boston Medical Group
• Contact: Carolina Sandoval, MSc
• Phone: +573133920816
• Email: csandoval[@]bostonmedical.com.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

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.

Locations

Country	Name	City	State
Colombia	Boston Medical Group	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Group

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical improvement	Three-fold increase in intravaginal ejaculatory latency time	weeks 12 and 24