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

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Department of Urology- Tanra University Hospitals
RECRUITING
Tanta
Contact Information
Primary
Mohamed I Elmaadawy, MD
Mohamed.elmaadawy@med.tanta.edu.eg
+201060245430
Backup
Hany F Badawy, MD
Hanyfathy86@gmail.com
+201149525028
Time Frame
Start Date: 2026-04-26
Estimated Completion Date: 2027-04
Participants
Target number of participants: 150
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov