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临床试验/NCT06570512
NCT06570512已完成不适用

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

Cairo University3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
3
主要终点
Intravaginal ejaculation latency time (ILET)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Intravaginal ejaculation latency time (ILET)

时间窗: 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.

Score of Arabic index of premature ejaculation (AIPE)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Fawzy Ghaly

Doctor

Cairo University

研究点 (3)

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