Skip to main content
OpenTrials
Completed

NCT Number: NCT07385222

Pelvic Floor Muscle Training With or Without Extracorporeal Magnetic Innervation for Premature Ejaculation

This is a single-center, prospective interventional study comparing pelvic floor muscle training (PFMT) alone versus PFMT combined with extracorporeal magnetic innervation (ExMI) in men with premature ejaculation (PE). The objective was to determine whether adding ExMI to standard PFMT improves pelvic floor function and patient-reported sexual outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature (Early) Ejaculation Ejaculatory Dysfunction Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Ejaculation Sexual Dysfunction Male Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences

Bolu, Merkez, 14100, Turkey (Türkiye)

About this study

This is a single-center, prospective interventional study that prospectively evaluated two nonpharmacological approaches for the management of premature ejaculation (PE): pelvic floor muscle training (PFMT) alone versus PFMT combined with extracorporeal magnetic innervation (ExMI). Adult men with clinically diagnosed PE were enrolled at a university hospital physiotherapy/urology clinic and followed over an 8-week intervention period. The trial was open-label with parallel groups; participants received the treatment used in clinical practice (PFMT only or PFMT+ExMI), and outcomes were collected prospectively according to a predefined protocol.

PE is common and impairs quality of life. PFMT may improve neuromuscular control of the pelvic floor, and ExMI delivers chair-based magnetic stimulation to activate pelvic floor musculature. We hypothesized that adding ExMI to standard PFMT would produce greater improvements in pelvic floor function and patient-reported sexual outcomes than PFMT alone.

All participants received structured education and a progressive, home-based PFMT program supervised during the 8-week period. The PFMT+ExMI group additionally underwent chair-based magnetic stimulation delivered per the clinic's predefined protocol targeting pelvic floor muscles.

Assessments were performed at baseline and post-intervention (week 8), with short-term follow-up where feasible. Primary outcomes were pelvic floor muscle displacement distance and endurance measured with real-time suprapubic ultrasonography under standardized instructions. Secondary outcomes included the Premature Ejaculation Diagnostic Tool (PEDT), International Index of Erectile Function (IIEF-5), Male Sexual Function Inventory-Short Form (MSFI-SF), WHOQOL-BREF sexual satisfaction item, Global Perceived Effect, and safety/adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, 25-45 years, sexually active
  • Clinical diagnosis of premature ejaculation by a specialist
  • Able to comply with PFMT and assessments
  • Complete baseline clinical/ultrasound records

Exclusion criteria

  • Neurologic disease (e.g., multiple sclerosis)
  • Metabolic/systemic/psychiatric disorders impacting outcomes
  • Significant cardiovascular disease
  • Medications affecting erection/ejaculation
  • Chronic prostatitis/urethritis or active UTI
  • Peyronie's disease or prior penile prosthesis at baseline

Treatment and study plan

Pelvic floor muscle training

Behavioral

Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period.

Extracorporeal Magnetic Innervation

Device

PFMT as in Arm A, plus chair-based magnetic stimulation delivered per predefined clinic protocol over 8 weeks.

Primary outcomes

  1. Pelvic floor muscle displacement distance (mm) on real-time suprapubic ultrasonography

    Time frame: Baseline, Week 4 and Week 8 (post-intervention)

    Change from baseline in cranio-caudal displacement during standardized contraction.

  2. Pelvic floor muscle endurance (seconds) on real-time suprapubic ultrasonography

    Time frame: Baseline, Week 4 and Week 8

    Change from baseline in sustained contraction time under standardized instruction.

Secondary outcomes

  1. Premature Ejaculation Diagnostic Tool

    Time frame: Baseline, Week 4 and Week 8

    This five-item, Likert-type self-report form measures the severity of premature ejaculation by assessing ejaculation control, intravaginal ejaculation time, and emotional impact.

  2. Male Sexual Function Inventory-Short Form

    Time frame: Baseline, Week 4 and Week 8

    This instrument evaluates male sexuality in terms of functional domains and allows for the analysis of psychometric properties related to overall sexual satisfaction. Each item is rated on a Likert scale ranging from 0 (dysfunction/severe problem) to 4 (good function/no problem)

  3. International Index of Erectile Function

    Time frame: Baseline, Week 4 and Week 8

    This self-assessment tool is widely used to determine the severity of erectile dysfunction.

  4. World Health Organization Quality-of-Life Scale-BREF

    Time frame: Baseline, Week 4 and Week 8

    This tool enables individuals to subjectively assess their quality of life in physical, psychological, social, and environmental domains within their own cultural context.

  5. Global Perceived Effect Scale

    Time frame: at Week 8

    This scale aims to measure how individuals experience recovery processes in relation to factors such as health status, emotional state, perceived stress, and social support.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

A Single-Center Prospective Interventional Study Comparing Pelvic Floor Muscle Training Alone Versus Combined With Extracorporeal Magnetic Innervation in Men With Premature Ejaculation

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.