Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation

NCT07385222 | Completed

• 1 other identifier: AIBU-FTR-MFU-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, parallel-group randomized controlled trial evaluated whether extracorporeal magnetic innervation (ExMI) added to pelvic floor muscle training (PFMT) improves pelvic floor muscle function and premature ejaculation symptoms compared with PFMT alone in men with premature ejaculation. Participants were assessed at baseline, week 4, and week 8 using real-time suprapubic ultrasonography and validated patient-reported outcome measures.

Conditions

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

Keywords

premature ejaculation; pelvic floor; pelvic floor muscle training; magnetic field therapy; ultrasonography; extracorporeal magnetic innervation

Outcome Measures

Primary Outcomes (2)

• Pelvic Floor Muscle Displacement (mm) Assessed by Real-Time Suprapubic Ultrasonography

  Pelvic floor muscle activation was assessed by measuring displacement of the caudal border of the prostate from rest to maximal voluntary pelvic floor contraction using real-time suprapubic ultrasonography. Three contractions were recorded and averaged. Greater displacement indicates greater pelvic floor muscle activation.

  Baseline, Week 4, and Week 8

• Pelvic floor muscle endurance (seconds) on real-time suprapubic ultrasonography

  Pelvic floor muscle endurance was defined as the duration, in seconds, for which the participant could maintain maximal visible pelvic floor elevation during voluntary contraction under real-time suprapubic ultrasonography. Longer duration indicates greater pelvic floor muscle endurance.

  Baseline, Week 4 and Week 8

Secondary Outcomes (6)

• Premature Ejaculation Diagnostic Tool (PEDT)

  Baseline, Week 4 and Week 8

• Brief Sexual Function Inventory (BSFI)

  Baseline, Week 4 and Week 8

• Five-Item International Index of Erectile Function (IIEF-5)

  Baseline, Week 4 and Week 8

• World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score

  Baseline, Week 4 and Week 8

• Exploratory WHOQOL-BREF Sexual Satisfaction Item

  Baseline, Week 4, and Week 8

Study Arms (2)

Arm A - Pelvic Floor Muscle Training (PFMT)

ACTIVE COMPARATOR

Participants received structured education about pelvic floor anatomy and function and completed an 8-week progressive home-based pelvic floor muscle training program. The program included both slow and fast pelvic floor muscle contractions performed in five sets daily.

Behavioral: Pelvic Floor Muscle Training

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

EXPERIMENTAL

Participants completed the same 8-week progressive pelvic floor muscle training program as Arm A and additionally received chair-based extracorporeal magnetic innervation twice weekly for 8 weeks, for a total of 16 sessions.

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

Interventions

Pelvic Floor Muscle Training BEHAVIORAL

Participants performed five sets of pelvic floor muscle exercises daily for 8 weeks. Each set included slow and fast contractions. The number of each type of contraction was progressively increased from 10 in week 1, to 20 in week 2, 30 in week 3, and 40 in week 4. During weeks 5-8, each set included 50 slow and 50 fast contractions. Correct pelvic floor contraction was taught and verified using real-time ultrasonography.

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

Extracorporeal Magnetic Innervation DEVICE

Extracorporeal magnetic innervation was delivered using the EMD E-6000 MAGTHER system with the participant seated on the treatment chair. Treatment was administered twice weekly for 8 weeks, for a total of 16 sessions. Each session consisted of 10 minutes of intermittent stimulation at 10 Hz, followed by a 1-minute rest period and 10 minutes of intermittent stimulation at 50 Hz. Stimulation intensity was increased to the highest comfortably tolerated level.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male adults with premature ejaculation diagnosed by a specialist physician
• Sexually active
• Literate and able to understand study instructions
• Voluntary participation with informed consent
• Able to cooperate with study assessments and pelvic floor muscle training

You may not qualify if:

• Medication use or medical conditions likely to affect erection or ejaculation
• Metabolic, chronic systemic, psychiatric, or significant cardiovascular disorders
• Alcohol or substance dependence
• Peyronie's disease
• Chronic prostatitis
• Urethritis
• Active urinary tract infection
• Documented abnormal semen quality
• Mental or cognitive problems preventing adequate cooperation with study procedures

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University, Faculty of Health Sciences

Bolu, Merkez, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Ejaculatory Dysfunction; Premature Ejaculation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel-group randomized controlled trial with two treatment arms

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: October 14, 2019
• Primary Completion: February 8, 2023
• Study Completion: March 8, 2023
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)