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

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

Study Overview

• Status: Completed
• Conditions: Ejaculatory Dysfunction; Sexual Dysfunction Male; Premature (Early) Ejaculation
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training; Device: Extracorporeal Magnetic Innervation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Bolu, Merkez, Turkey (Türkiye), 14100
      • Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A - Pelvic Floor Muscle Training (PFMT); Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period.	Behavioral: Pelvic Floor Muscle Training; Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period.
Experimental: Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI); PFMT as in Arm A, plus chair-based magnetic stimulation delivered per predefined clinic protocol over 8 weeks.	Behavioral: Pelvic Floor Muscle Training; Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period.; Device: Extracorporeal Magnetic Innervation; PFMT as in Arm A, plus chair-based magnetic stimulation delivered per predefined clinic protocol over 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic floor muscle displacement distance (mm) on real-time suprapubic ultrasonography	Change from baseline in cranio-caudal displacement during standardized contraction.	Baseline, Week 4 and Week 8 (post-intervention)
Pelvic floor muscle endurance (seconds) on real-time suprapubic ultrasonography	Change from baseline in sustained contraction time under standardized instruction.	Baseline, Week 4 and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Ejaculation Diagnostic Tool	This five-item, Likert-type self-report form measures the severity of premature ejaculation by assessing ejaculation control, intravaginal ejaculation time, and emotional impact.	Baseline, Week 4 and Week 8
Male Sexual Function Inventory-Short Form	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)	Baseline, Week 4 and Week 8
International Index of Erectile Function	This self-assessment tool is widely used to determine the severity of erectile dysfunction.	Baseline, Week 4 and Week 8
World Health Organization Quality-of-Life Scale-BREF	This tool enables individuals to subjectively assess their quality of life in physical, psychological, social, and environmental domains within their own cultural context.	Baseline, Week 4 and Week 8
Global Perceived Effect Scale	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.	at Week 8

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: ultrasonography; premature ejaculation; magnetic field therapy; pelvic floor; pelvic floor muscle training
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Ejaculatory Dysfunction; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: AIBU-FTR-MFU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No