NCT07385222

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2025

Enrollment Period

3.3 years

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Premature (Early) EjaculationEjaculatory DysfunctionSexual Dysfunction Male

Keywords

premature ejaculationpelvic floorpelvic floor muscle trainingmagnetic field therapyultrasonography

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (5)

  • Premature Ejaculation Diagnostic Tool

    Baseline, Week 4 and Week 8

  • Male Sexual Function Inventory-Short Form

    Baseline, Week 4 and Week 8

  • International Index of Erectile Function

    Baseline, Week 4 and Week 8

  • World Health Organization Quality-of-Life Scale-BREF

    Baseline, Week 4 and Week 8

  • Global Perceived Effect Scale

    at Week 8

Study Arms (2)

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.

Behavioral: Pelvic Floor Muscle Training

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.

Behavioral: Pelvic Floor Muscle TrainingDevice: Extracorporeal Magnetic Innervation

Interventions

Pelvic Floor Muscle TrainingBEHAVIORAL

Structured pelvic floor education plus a progressive home exercise program supervised during the 8-week period.

Arm A - Pelvic Floor Muscle Training (PFMT)Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI)
Extracorporeal Magnetic InnervationDEVICE

PFMT as in Arm A, plus chair-based magnetic stimulation delivered per predefined clinic protocol over 8 weeks.

Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI)

Eligibility Criteria

Age25 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale only.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male, 25-45 years, sexually active
  • Clinical diagnosis of premature ejaculation by a specialist
  • Able to comply with PFMT and assessments
  • Complete baseline clinical/ultrasound records

You may not qualify if:

  • Neurologic disease (e.g., multiple sclerosis)
  • Metabolic/systemic/psychiatric disorders impacting outcomes
  • Significant cardiovascular disease
  • Medications affecting erection/ejaculation
  • Chronic prostatitis/urethritis or active UTI
  • Peyronie's disease or prior penile prosthesis at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature BirthEjaculatory DysfunctionPremature Ejaculation

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases, MaleGenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel-group controlled interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

October 14, 2019

Primary Completion

February 8, 2023

Study Completion

March 8, 2023

Last Updated

February 4, 2026

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)