A Single-Center Prospective Interventional Study Comparing Pelvic Floor Muscle Training Alone Versus Combined With Extracorporeal Magnetic Innervation in Men With Premature Ejaculation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Pelvic floor muscle displacement distance (mm) on real-time suprapubic ultrasonography
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm A - Pelvic Floor Muscle Training (PFMT)
Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period.
Intervention: Pelvic Floor Muscle Training (Behavioral)
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.
Intervention: Pelvic Floor Muscle Training (Behavioral)
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.
Intervention: Extracorporeal Magnetic Innervation (Device)
Outcomes
Primary Outcomes
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.
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
- Premature Ejaculation Diagnostic Tool(Baseline, Week 4 and Week 8)
- Male Sexual Function Inventory-Short Form(Baseline, Week 4 and Week 8)
- International Index of Erectile Function(Baseline, Week 4 and Week 8)
- World Health Organization Quality-of-Life Scale-BREF(Baseline, Week 4 and Week 8)
- Global Perceived Effect Scale(at Week 8)
Investigators
Fatih UYSAL
Assistant Professor
Abant Izzet Baysal University