Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation

Effects of Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Ejaculatory Dysfunction; Sexual Dysfunction Male; Premature (Early) Ejaculation
• Intervention / Treatment: Behavioral: Pelvic Floor Muscle Training; Device: Extracorporeal Magnetic Innervation

Detailed Description

This single-center, prospective, parallel-group randomized controlled trial compared pelvic floor muscle training (PFMT) alone with the same PFMT program combined with extracorporeal magnetic innervation (ExMI) in adult men diagnosed with premature ejaculation by a specialist physician.

Random allocation was implemented using a study-specific Microsoft Excel worksheet. Consecutive participants were handled in blocks of two. For the first participant in each block, an integer from 1 to 100 was generated using the Excel RANDBETWEEN function. Odd numbers allocated the participant to the PFMT group and even numbers allocated the participant to the PFMT+ExMI group. The second participant in each block was assigned to the alternate group. A new random number was generated for each subsequent block.

Twenty complete two-participant blocks resulted in 40 randomized participants, with 20 allocated to each group. A 21st block was subsequently initiated, and its first participant generated an odd number and was allocated to the PFMT group. Thus, the randomized cohort comprised 41 participants (PFMT, n=21; PFMT+ExMI, n=20). This participant did not complete the week-8 assessment. Three additional participants were subsequently recruited to the PFMT arm as replacement attempts following this withdrawal. These three participants were outside the randomization sequence and were not included in the primary randomized analysis.

All randomized participants received structured education about pelvic floor anatomy and function and completed an 8-week progressive home-based PFMT program. Participants allocated to the PFMT+ExMI group additionally received chair-based extracorporeal magnetic innervation twice weekly for 8 weeks, for a total of 16 sessions. Each ExMI 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.

Assessments were performed at baseline, week 4, and week 8. The primary outcomes were pelvic floor muscle displacement and pelvic floor muscle endurance assessed using real-time suprapubic ultrasonography. Secondary outcomes included premature ejaculation symptoms assessed with the Premature Ejaculation Diagnostic Tool (PEDT), sexual function assessed with the Brief Sexual Function Inventory (BSFI), erectile function assessed with the five-item International Index of Erectile Function (IIEF-5), quality of life assessed with the WHOQOL-BREF, and perceived improvement assessed with the Global Perceived Effect Scale.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Bolu, Merkez, Turkey (Türkiye), 14030
      • Bolu Abant Izzet Baysal University, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A - Pelvic Floor Muscle Training (PFMT); 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; 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.
Experimental: Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI); 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; 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.; Device: Extracorporeal Magnetic Innervation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Ejaculation Diagnostic Tool (PEDT)	The Premature Ejaculation Diagnostic Tool (PEDT) is a 5-item patient-reported questionnaire assessing ejaculatory control, frequency, minimal stimulation, distress, and interpersonal difficulty related to premature ejaculation. Total scores range from 0 to 20, with higher scores indicating more severe premature ejaculation symptoms.	Baseline, Week 4 and Week 8
Brief Sexual Function Inventory (BSFI)	The Brief Sexual Function Inventory (BSFI) assesses male sexual function across domains including sexual drive, erection, ejaculation, problem assessment, and overall satisfaction. The total score used in this study ranges from 0 to 44, with higher scores indicating better sexual function.	Baseline, Week 4 and Week 8
Five-Item International Index of Erectile Function (IIEF-5)	The five-item International Index of Erectile Function (IIEF-5) assesses erectile function. Total scores range from 5 to 25, with higher scores indicating better erectile function.	Baseline, Week 4 and Week 8
World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score	The World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a 26-item questionnaire assessing perceived quality of life. In this study, the raw total score across all 26 items was used. Possible total scores range from 26 to 130, with higher scores indicating better quality of life.	Baseline, Week 4 and Week 8
Exploratory WHOQOL-BREF Sexual Satisfaction Item	Sexual satisfaction was assessed using the sexual satisfaction item of the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF). The item is scored from 1 to 5, with higher scores indicating greater satisfaction with sexual life. This item was analysed as an exploratory outcome.	Baseline, Week 4, and Week 8
Global Perceived Effect Scale (GPES)	The Global Perceived Effect Scale (GPES) assessed the participant's perceived overall improvement following treatment. Participants rated their perceived improvement on a scale from 0 to 10, where 0 indicated no improvement and 10 indicated satisfactory/maximal perceived improvement. Higher scores indicate greater perceived improvement.	at Week 8

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 9, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: ultrasonography; premature ejaculation; magnetic field therapy; pelvic floor; pelvic floor muscle training; extracorporeal magnetic innervation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Ejaculatory Dysfunction; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: AIBU-FTR-MFU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan for public sharing of individual participant data. The original informed consent and ethics approval did not include public deposition of participant-level data. De-identified data may be considered for sharing on reasonable request, subject to institutional and ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No