Premature (Early) EjaculationNCT07385222
Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation
A study testing Pelvic Floor Muscle Training and Extracorporeal Magnetic Innervation in people with Premature (Early) Ejaculation and Ejaculatory Dysfunction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Premature (Early) Ejaculation, Ejaculatory Dysfunction, Sexual Dysfunction Male
- What is being tested?
- Pelvic Floor Muscle Training and Extracorporeal Magnetic Innervation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2019to 8 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active urinary tract infection
- Documented abnormal semen quality
- Mental or cognitive problems preventing adequate cooperation with study procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Faculty of Health Sciences
Bolu, Merkez, 14030
About this study
Official title: Effects of Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Pelvic Floor Muscle Training, Extracorporeal Magnetic Innervation
- Keywords
- premature ejaculation, pelvic floor, pelvic floor muscle training, magnetic field therapy, ultrasonography, extracorporeal magnetic innervation
- Medical subject headings
- Premature Birth, Ejaculatory Dysfunction, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Pelvic Floor Muscle Training (PFMT) | Active comparator | 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. Receives: Behavioral: Pelvic Floor Muscle Training |
| Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI) | Experimental | 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. Receives: Behavioral: Pelvic Floor Muscle Training; Device: Extracorporeal Magnetic Innervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 4 and Week 8
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start14 Oct 2019
- Primary completion8 Feb 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature (Early) EjaculationStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group randomized controlled trial with two treatment arms
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih UYSAL, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385222
- Sponsor's protocol ID
- AIBU-FTR-MFU-01
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Magnetic Innervation Plus Pelvic Floor Muscle Training for Premature Ejaculation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07385222
- Acronym / sponsor ID
- AIBU-FTR-MFU-01
- Keywords
- premature ejaculation, pelvic floor, pelvic floor muscle training, magnetic field therapy, ultrasonography, extracorporeal magnetic innervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled trial with two treatment arms
| Arm | Type | Receives |
|---|---|---|
| Arm A - Pelvic Floor Muscle Training (PFMT) | Active comparator | Behavioral: Pelvic Floor Muscle TrainingParticipants 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. |
| Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI) | Experimental | Behavioral: Pelvic Floor Muscle Training, Device: Extracorporeal Magnetic InnervationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic Floor Muscle TrainingParticipants 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. | Behavioural | Arm A - Pelvic Floor Muscle Training (PFMT), Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI) |
| Extracorporeal Magnetic InnervationExtracorporeal 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. | Device | Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI) |
Primary outcome
Pelvic Floor Muscle Displacement (mm) Assessed by Real-Time Suprapubic Ultrasonography
Time frame: 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
Time frame: 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.
6 secondary outcomes
Premature Ejaculation Diagnostic Tool (PEDT)
Time frame: Baseline, Week 4 and Week 8
Brief Sexual Function Inventory (BSFI)
Time frame: Baseline, Week 4 and Week 8
Five-Item International Index of Erectile Function (IIEF-5)
Time frame: Baseline, Week 4 and Week 8
World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score
Time frame: Baseline, Week 4 and Week 8
Exploratory WHOQOL-BREF Sexual Satisfaction Item
Time frame: Baseline, Week 4, and Week 8
Global Perceived Effect Scale (GPES)
Time frame: at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training and Extracorporeal Magnetic Innervation in people with Premature (Early) Ejaculation and Ejaculatory Dysfunction, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscle Displacement (mm) Assessed by Real-Time Suprapubic Ultrasonography (time frame: Baseline, Week 4, and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.