NCT07385222

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Abant Izzet Baysal University · Academic / Other
• Sex: Male
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Premature (Early) Ejaculation
• Ejaculatory Dysfunction
• Sexual Dysfunction Male

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-14
• Primary completion: 2023-02-08
• Completion: 2023-03-08
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Turkey (Türkiye)