Pelvic Floor Therapies for Lifelong Premature Ejaculation (PE-PFMT)

May 30, 2026 updated by: Mohamed Ibrahim Ahmed Elmaadawy, Tanta University

Electromagnetic Pelvic Floor Stimulation Versus Biofeedback-Assisted and Conventional Pelvic Floor Muscle Training in Men With Lifelong Premature Ejaculation: A Randomized Controlled Trial

This randomized controlled trial will compare three pelvic floor-based treatment modalities in men with lifelong premature ejaculation: electromagnetic pelvic floor stimulation, biofeedback-assisted pelvic floor muscle training, and conventional pelvic floor muscle training. A total of 150 men aged 18 to 50 years with lifelong premature ejaculation and stopwatch-measured intravaginal ejaculatory latency time of less than 1 minute will be randomly assigned to one of the three treatment groups. The primary outcome will be the change in intravaginal ejaculatory latency time from baseline to the end of treatment at 6 weeks. Secondary outcomes will include changes in Premature Ejaculation Diagnostic Tool score, International Index of Erectile Function-5 score, patient-reported ejaculatory control, sexual satisfaction, partner satisfaction, treatment adherence, and adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premature ejaculation is one of the most common male sexual dysfunctions and may negatively affect quality of life, sexual satisfaction, and interpersonal relationships. Pelvic floor muscles, particularly the bulbocavernosus and ischiocavernosus muscles, are involved in ejaculatory control. Pelvic floor muscle training has been used as a non-pharmacological treatment for premature ejaculation; however, its effectiveness may be limited by incorrect muscle identification and poor adherence. Biofeedback-assisted pelvic floor muscle training may improve patient awareness and neuromuscular coordination. Electromagnetic pelvic floor stimulation is a non-invasive modality designed to induce repeated pelvic floor muscle contractions and may improve pelvic floor muscle function.

After approval by the Research Ethics Committee, Faculty of Medicine, Tanta University, eligible participants will be recruited from the outpatient clinic of the Urology Department, Tanta University. Men aged 18 to 50 years with lifelong premature ejaculation and intravaginal ejaculatory latency time of less than 1 minute will be enrolled after providing written informed consent. Participants will be randomly assigned in a 1:1:1 ratio to receive electromagnetic pelvic floor stimulation, biofeedback-assisted pelvic floor muscle training, or conventional pelvic floor muscle training.

Baseline assessment will include medical and sexual history, physical examination, stopwatch-measured intravaginal ejaculatory latency time, Premature Ejaculation Diagnostic Tool score, International Index of Erectile Function-5 score, patient-reported ejaculatory control, sexual satisfaction, and partner satisfaction. Intravaginal ejaculatory latency time will be calculated as the average of at least three consecutive intercourse attempts. Outcomes will be assessed at baseline, at the end of treatment at 6 weeks, and at 3-month follow-up. Treatment adherence and adverse events will be recorded throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Tanta
      • Tanta, Tanta, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men aged 18 to 50 years.
  • Diagnosis of lifelong premature ejaculation.
  • Intravaginal ejaculatory latency time less than 1 minute.
  • Ability and willingness to comply with the treatment protocol and follow-up visits.
  • Written informed consent.

Exclusion Criteria:

  • Erectile dysfunction.
  • Neurological disease.
  • Previous pelvic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Electromagnetic Pelvic Floor Stimulation
Participants allocated to this arm will receive non-invasive electromagnetic pelvic floor stimulation over a 6-week treatment period according to the institutional pelvic floor rehabilitation protocol.
Device: Electromagnetic Pelvic Floor Stimulation
Non-invasive electromagnetic pelvic floor stimulation will be applied to induce repeated pelvic floor muscle contractions. Treatment will be delivered over 6 weeks according to the institutional pelvic floor rehabilitation protocol.
Active Comparator: Biofeedback-Assisted Pelvic Floor Muscle Training
Participants allocated to this arm will receive supervised pelvic floor muscle training assisted by biofeedback over a 6-week treatment period to improve pelvic floor muscle awareness, contraction, relaxation, and coordination.
Behavioral: Biofeedback-Assisted Pelvic Floor Muscle Training
Participants will receive supervised pelvic floor muscle training assisted by biofeedback over a 6-week treatment period to improve pelvic floor muscle awareness, contraction, relaxation, and coordination.
Active Comparator: Conventional Pelvic Floor Muscle Training
Participants allocated to this arm will receive conventional pelvic floor muscle training over a 6-week treatment period according to the institutional pelvic floor rehabilitation protocol.
Behavioral: Conventional Pelvic Floor Muscle Training
Participants will receive conventional pelvic floor muscle training aimed at improving pelvic floor muscle control and ejaculatory control. Treatment will be delivered over 6 weeks according to the institutional physiotherapy protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
Time Frame: Baseline and 6 weeks
Intravaginal ejaculatory latency time will be measured using a stopwatch. The average of at least three consecutive intercourse attempts will be recorded. The outcome will be expressed as the change in intravaginal ejaculatory latency time from baseline to the end of treatment at 6 weeks.
Baseline and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Intravaginal Ejaculatory Latency Time at 3 Months
Time Frame: Baseline and 3 months
Intravaginal ejaculatory latency time will be measured using a stopwatch. The average of at least three consecutive intercourse attempts will be recorded. The outcome will be expressed as the change from baseline to 3-month follow-up.
Baseline and 3 months
Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks
Time Frame: Baseline and 6 weeks
The Premature Ejaculation Diagnostic Tool will be used to assess the severity of premature ejaculation. The outcome will be expressed as the change in total score from baseline to 6 weeks.
Baseline and 6 weeks
Change in Patient-Reported Ejaculatory Control at 6 Weeks
Time Frame: Baseline and 6 weeks
Patient-reported ejaculatory control will be assessed using a Likert scale. The outcome will be expressed as the change from baseline to 6 weeks.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed I Elmaadawy, MD, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PEPFMT36265PR25426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study involves sensitive individual-level sexual health data. Results will be reported only in aggregated, de-identified form. Any future sharing of anonymized data would require additional ethics committee approval and compliance with participant consent and institutional regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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