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This is a single-center, prospective interventional study comparing pelvic floor muscle training (PFMT) alone versus PFMT combined with extracorporeal magnetic innervation (ExMI) in men with premature ejaculation (PE). The objective was to determine whether adding ExMI to standard PFMT improves pelvic floor function and patient-reported sexual outcomes.
This is a single-center, prospective interventional study that prospectively evaluated two nonpharmacological approaches for the management of premature ejaculation (PE): pelvic floor muscle training (PFMT) alone versus PFMT combined with extracorporeal magnetic innervation (ExMI). Adult men with clinically diagnosed PE were enrolled at a university hospital physiotherapy/urology clinic and followed over an 8-week intervention period. The trial was open-label with parallel groups; participants received the treatment used in clinical practice (PFMT only or PFMT+ExMI), and outcomes were collected prospectively according to a predefined protocol.
PE is common and impairs quality of life. PFMT may improve neuromuscular control of the pelvic floor, and ExMI delivers chair-based magnetic stimulation to activate pelvic floor musculature. We hypothesized that adding ExMI to standard PFMT would produce greater improvements in pelvic floor function and patient-reported sexual outcomes than PFMT alone.
All participants received structured education and a progressive, home-based PFMT program supervised during the 8-week period. The PFMT+ExMI group additionally underwent chair-based magnetic stimulation delivered per the clinic's predefined protocol targeting pelvic floor muscles.
Assessments were performed at baseline and post-intervention (week 8), with short-term follow-up where feasible. Primary outcomes were pelvic floor muscle displacement distance and endurance measured with real-time suprapubic ultrasonography under standardized instructions. Secondary outcomes included the Premature Ejaculation Diagnostic Tool (PEDT), International Index of Erectile Function (IIEF-5), Male Sexual Function Inventory-Short Form (MSFI-SF), WHOQOL-BREF sexual satisfaction item, Global Perceived Effect, and safety/adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Pelvic Floor Muscle Training (PFMT) | Active Comparator | Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period. |
|
| Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI) | Experimental | PFMT as in Arm A, plus chair-based magnetic stimulation delivered per predefined clinic protocol over 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Muscle Training | Behavioral | Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic floor muscle displacement distance (mm) on real-time suprapubic ultrasonography | Change from baseline in cranio-caudal displacement during standardized contraction. | Baseline, Week 4 and Week 8 (post-intervention) |
| Pelvic floor muscle endurance (seconds) on real-time suprapubic ultrasonography | Change from baseline in sustained contraction time under standardized instruction. | Baseline, Week 4 and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Premature Ejaculation Diagnostic Tool | This five-item, Likert-type self-report form measures the severity of premature ejaculation by assessing ejaculation control, intravaginal ejaculation time, and emotional impact. | Baseline, Week 4 and Week 8 |
| Male Sexual Function Inventory-Short Form |
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Inclusion Criteria:
Exclusion Criteria:
Male only.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences | Bolu | Merkez | 14100 | Turkey (Türkiye) |
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parallel-group controlled interventional study
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| Extracorporeal Magnetic Innervation | Device | PFMT as in Arm A, plus chair-based magnetic stimulation delivered per predefined clinic protocol over 8 weeks. |
|
This instrument evaluates male sexuality in terms of functional domains and allows for the analysis of psychometric properties related to overall sexual satisfaction. Each item is rated on a Likert scale ranging from 0 (dysfunction/severe problem) to 4 (good function/no problem) |
| Baseline, Week 4 and Week 8 |
| International Index of Erectile Function | This self-assessment tool is widely used to determine the severity of erectile dysfunction. | Baseline, Week 4 and Week 8 |
| World Health Organization Quality-of-Life Scale-BREF | This tool enables individuals to subjectively assess their quality of life in physical, psychological, social, and environmental domains within their own cultural context. | Baseline, Week 4 and Week 8 |
| Global Perceived Effect Scale | This scale aims to measure how individuals experience recovery processes in relation to factors such as health status, emotional state, perceived stress, and social support. | at Week 8 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D000097910 | Ejaculatory Dysfunction |
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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