Transcutaneous Electrical Nerve Stimulation for the Treatment of Premature Ejaculation

NCT ID: NCT06570512

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-09

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).

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.

Conditions

Transcutaneous Electrical Nerve Stimulation; Premature Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

transcutaneous posterior tibial nerve stimulation

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

transcutaneous posterior tibial nerve stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

sham transcutaneous electrical nerve stimulation (TENS).

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Department of Andrology & STDs Kasr AlAiny Cairo University

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Fawzy Ghaly

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, Giza Governorate, Egypt

Faculty Of Medicine, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

TPTNS for PE

Identifier Type: -

Identifier Source: org_study_id