An interventional study of Pelvic Floor Muscle Training and Extracorporeal Magnetic Innervation in Premature (Early) Ejaculation, Ejaculatory Dysfunction and Sexual Dysfunction Male, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 44 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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 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.
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.
Time frame: Baseline, Week 4 and Week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at Week 8
Plan to share: No — 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.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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