Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation

Abant Izzet Baysal University44 enrolled

Overview

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.

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.

Interventions

Pelvic Floor Muscle TrainingBEHAVIORAL

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.

Extracorporeal Magnetic InnervationDEVICE

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.