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Clinical Trials/NCT07385222
NCT07385222
Completed
Not Applicable

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

Abant Izzet Baysal University1 site in 1 country41 target enrollmentStarted: October 14, 2019Last updated:

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)

Active Comparator

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)

Experimental

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)

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatih UYSAL

Assistant Professor

Abant Izzet Baysal University

Study Sites (1)

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