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

Abant Izzet Baysal University

Status: Completed

Conditions: Sexual Dysfunction Male; Ejaculatory Dysfunction; Premature (Early) Ejaculation

Treatments: Behavioral: Pelvic Floor Muscle Training; Device: Extracorporeal Magnetic Innervation

Study type: Interventional

Funder types: Other

Identifiers

NCT07385222

AIBU-FTR-MFU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Arm A - Pelvic Floor Muscle Training (PFMT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Pelvic Floor Muscle Training

Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI)

Experimental group

Description:

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

Treatment:

Device: Extracorporeal Magnetic Innervation

Behavioral: Pelvic Floor Muscle Training