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Transcutaneous Electrical Nerve Stimulation for the Treatment of Premature Ejaculation

NCT06570512 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Department of Andrology & STDs Kasr AlAiny Cairo University

    collaborator UNKNOWN

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-05-01
Completion
2023-12-09
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06570512 on ClinicalTrials.gov