Pelvic Floor Therapies for Lifelong Premature Ejaculation

NCT07627438 | Recruiting

• 1 other identifier: PEPFMT36265PR25426
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ejaculation; Lifelong Premature Ejaculation; Male Sexual Dysfunction

Keywords

Pelvic floor muscle training; Biofeedback; Electromagnetic pelvic floor stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Intravaginal Ejaculatory Latency Time at 3 Months

  Baseline and 3 months

• Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks

  Baseline and 6 weeks

• Change in Patient-Reported Ejaculatory Control at 6 Weeks

  Baseline and 6 weeks

Study Arms (3)

Electromagnetic Pelvic Floor Stimulation

EXPERIMENTAL

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

Biofeedback-Assisted Pelvic Floor Muscle Training

ACTIVE COMPARATOR

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

Conventional Pelvic Floor Muscle Training

ACTIVE COMPARATOR

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

Interventions

Electromagnetic Pelvic Floor Stimulation DEVICE

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.

Electromagnetic Pelvic Floor Stimulation

Biofeedback-Assisted Pelvic Floor Muscle Training BEHAVIORAL

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.

Biofeedback-Assisted Pelvic Floor Muscle Training

Conventional Pelvic Floor Muscle Training BEHAVIORAL

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.

Conventional Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Department of Urology- Tanra University Hospitals

Tanta, Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Mohamed I Elmaadawy, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed I Elmaadawy, MD

CONTACT

+201060245430; Mohamed.elmaadawy@med.tanta.edu.eg

Hany F Badawy, MD

CONTACT

+201149525028; Hanyfathy86@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by an assessor who will be blinded to treatment allocation. Participants and treatment providers cannot be blinded because of the nature of the physical and behavioral interventions. Treatment allocation will not be disclosed to the outcome assessor during follow-up data collection and analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Tanta University

Model Details: Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel treatment groups: electromagnetic pelvic floor stimulation, biofeedback-assisted pelvic floor muscle training, or conventional pelvic floor muscle training.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: April 26, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)