Transcutaneous Electrical Nerve Stimulation for the Treatment of Premature Ejaculation

NCT06570512 | Completed DMC FDA Device

• 1 other identifier: TPTNS for PE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Premature ejaculation (PE) is the most prevalent male sexual dysfunction. The currently approved treatments are intolerable to patients due to their side effects. the investigatorsconducted a blinded randomized controlled trial to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for the treatment of PE. 5o male patients complaining of PE with intravaginal ejaculation latency time (IELT) of less than 2 minutes were randomized into two equal groups to receive either TPTNS or sham transcutaneous electrical nerve stimulation (TENS). TPTNS group underwent ten sessions of electrical stimulation of the posterior tibial nerve using a frequency of 20 Hz and a pulse width of 250 microseconds. The primary outcomes were IELT which was calculated by the patient\'s digital hand watch, and the Arabic index of premature ejaculation (AIPE).

Conditions

Transcutaneous Electrical Nerve Stimulation; Premature Ejaculation

Keywords

premature ejaculation; transcutaneous electrical nerve stimulation; posterior tibial nerve

Outcome Measures

Primary Outcomes (2)

• Intravaginal ejaculation latency time (ILET)

  was calculated using the digital hand watch. The patients were instructed to count the time between intromission and ejaculation, and to repeat this procedure in one to two coital occasions per week over three weeks of receiving sessions and to continue for 2 months after end of sessions.

  at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up

• Score of Arabic index of premature ejaculation (AIPE)

  Seven item questionnaire developed by Arafa \& Shamloul in 2007 that evaluates sexual desire, hard erections for sufficient intercourse, time to ejaculation, control, satisfaction for the patient and partner, anxiety or depression.

  at the baseline (before starting the treatment sessions), then at 3 weeks (by the end of treatment) and finally 2 months later for follow up

Study Arms (2)

transcutaneous posterior tibial nerve stimulation (TPTNS)

EXPERIMENTAL

TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz

Device: transcutaneous posterior tibial nerve stimulation

sham transcutaneous electrical nerve stimulation (TENS).

ACTIVE COMPARATOR

TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes.

Device: transcutaneous posterior tibial nerve stimulation

Interventions

transcutaneous posterior tibial nerve stimulation DEVICE

Over three weeks, the TPTNS group underwent ten sessions of electrical stimulation along the course of the posterior tibial nerve behind the medial malleoli using cup electrodes, with a width pulse of 250 microseconds, and a frequency of 20 Hz. The TENS group used a sham device with the same parameters, but the electrodes were placed behind the lateral malleoli with underpowered amplitudes.

Also known as: sham transcutaneous electrical nerve stimulation (TENS).

sham transcutaneous electrical nerve stimulation (TENS).; transcutaneous posterior tibial nerve stimulation (TPTNS)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• married males
• with stable and continuous marital relationships
• diagnosed with premature ejaculation based on the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) : (a) within the 1-2 minutes after penetration, the ejaculation always or almost always starts; (b)in all or almost all penetrations, the patient cannot delay the ejaculation; (c) PE generate negative consequences on the patients, such as discomfort, frustration, stress, and/or sexual intimacy avoidance
• and the patient did not take the treatment for PE in the previous 14 days

You may not qualify if:

• Patients were excluded if they had erectile dysfunction (measured by the International Index of Erectile function-ILEF-5 questionnaire),
• inhibited male orgasm
• reduced sexual desire
• uncontrolled physical illness
• active genitourinary tract infection (confirmed by two glasses of urine according to Modified Meares-Stamey technique)
• mental disorders affecting ejaculatory function such as anxiety, depression, and schizophrenia, history of alcohol or drug abuse

Sponsors & Collaborators

• Cairo University: lead
• Department of Andrology & STDs Kasr AlAiny Cairo University: collaborator

Study Sites (2)

Cairo University

Cairo, Giza Governorate, Egypt

Location

Faculty Of Medicine, Cairo University

Cairo, 35744, Egypt

Location

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 26, 2024
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: December 9, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

EG (2)