Ejaculatory Dysfunction, Premature (Early) Ejaculation, Sexual Dysfunction Male
Conditions
Keywords
premature ejaculation, pelvic floor, pelvic floor muscle training, magnetic field therapy, ultrasonography, extracorporeal magnetic innervation
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.
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.
Interventions
BEHAVIORALPelvic 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.
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.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel-group randomized controlled trial with two treatment arms
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Displacement (mm) Assessed by Real-Time Suprapubic Ultrasonography | Baseline, Week 4, and Week 8 | 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. |
| Pelvic floor muscle endurance (seconds) on real-time suprapubic ultrasonography | Baseline, Week 4 and Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Premature Ejaculation Diagnostic Tool (PEDT) | Baseline, Week 4 and Week 8 | 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. |
| Brief Sexual Function Inventory (BSFI) | Baseline, Week 4 and Week 8 | 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. |
| Five-Item International Index of Erectile Function (IIEF-5) | Baseline, Week 4 and Week 8 | 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. |
| World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score | Baseline, Week 4 and Week 8 | 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. |
| Exploratory WHOQOL-BREF Sexual Satisfaction Item | Baseline, Week 4, and Week 8 | 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. |
| Global Perceived Effect Scale (GPES) | at Week 8 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed