Transcutaneous Electrical Nerve Stimulation for the Treatment of Premature Ejaculation

October 23, 2024 updated by: Mahmoud Fawzy Ghaly, Cairo University

Evaluation of the Transcutaneous Electrical Nerve Stimulation of the Posterior Tibial Nerve in the Treatment of Premature Ejaculation: A Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial design A single blinded randomized controlled trial was used, and the ratio of allocation was 1:1.

Between 2022 and 2023, this study was conducted on (50) male patients attending the outpatient clinic of Andrology, Kasr Al Ainy Hospital, Cairo University to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) to delay ejaculation in PE patients compared to sham transcutaneous electrical nerve stimulation (TENS).

Patients The participants included in this study were 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. 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. To exclude chronic prostatitis patients, the expressed prostatic secretions after prostatic massage were subjected to microscopic examination. Before conducting the study, informed consent was obtained from each patient.

The applied technique 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.

Outcome measures Before and after treatment, the patients were asked to answer the Arabic Index of premature ejaculation questionnaire (AIPE) which evaluates seven items: time to ejaculation, hard erections for sufficient intercourse, control, sexual desire, satisfaction for the patient and partner, anxiety, or depression. Also, the intravaginal ejaculation latency time (IELT) was calculated using the digital hand watch, as 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 after receiving either TPTNS or TENS. The ISSM defined an IELT threshold of 2 minutes as the cut-off point for PE. The treatment success was defined as a decrease in PE severity and an improvement in AIPE score.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 35744
        • Faculty of Medicine, Cairo University
    • Giza
      • Cairo, Giza, Egypt
        • Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transcutaneous posterior tibial nerve stimulation (TPTNS)
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
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.
Other Names:
  • sham transcutaneous electrical nerve stimulation (TENS).
Active Comparator: sham transcutaneous electrical nerve stimulation (TENS).
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
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.
Other Names:
  • sham transcutaneous electrical nerve stimulation (TENS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravaginal ejaculation latency time (ILET)
Time Frame: 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
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)
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to ejaculation
Time Frame: one to two post coital occasions per week over three weeks
time to ejaculation through Arabic Index of premature ejaculation questionnaire (AIPE)
one to two post coital occasions per week over three weeks
hard erections for sufficient intercourse
Time Frame: one to two post coital occasions per week over three weeks
hard erections for sufficient intercourse through Arabic Index of premature ejaculation questionnaire (AIPE)
one to two post coital occasions per week over three weeks
satisfaction for the patient and partner
Time Frame: one to two post coital occasions per week over three weeks
satisfaction for the patient and partner through Arabic Index of premature ejaculation questionnaire (AIPE)
one to two post coital occasions per week over three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Department of Andrology & STDs Kasr AlAiny Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

December 9, 2023

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPTNS for PE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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