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

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: Recruiting
• Conditions: Premature Ejaculation; Male Sexual Dysfunction; Lifelong Premature Ejaculation
• Intervention / Treatment: Device: Electromagnetic Pelvic Floor Stimulation; Behavioral: Biofeedback-Assisted Pelvic Floor Muscle Training; Behavioral: Conventional Pelvic Floor Muscle Training

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: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: Hanyfathy86@gmail.com
• Study Contact Backup: Name: Mohamed I Elmaadawy, MD; Phone Number: +201060245430; Email: Mohamed.elmaadawy@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta
    • Tanta, Tanta, Egypt
      • Recruiting
      • Department of Urology- Tanra University Hospitals
      • Contact: Mohamed I Elmaadawy, MD; Phone Number: +201060245430; Email: Mohamed.elmaadawy@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Intravaginal Ejaculatory Latency Time at 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

Outcome Measure	Measure Description	Time Frame
Change in Intravaginal Ejaculatory Latency Time at 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	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	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

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohamed I Elmaadawy, MD, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Biofeedback; Electromagnetic pelvic floor stimulation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Ejaculatory Dysfunction; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Premature Ejaculation
• Other Study ID 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