Pelvic Floor Therapies for Lifelong Premature Ejaculation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-50
SponsorTanta University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Erectile dysfunction.
Neurological disease.
Previous pelvic surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Electromagnetic Pelvic Floor Stimulation
DeviceNon-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.
Biofeedback-Assisted Pelvic Floor Muscle Training
BehavioralParticipants 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.
Conventional Pelvic Floor Muscle Training
BehavioralParticipants 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Electromagnetic Pelvic Floor StimulationExperimental treatment 1 intervention
Group B: Biofeedback-Assisted Pelvic Floor Muscle TrainingActive comparator 1 intervention
Group C: Conventional Pelvic Floor Muscle TrainingActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 6 weeksSecondary outcomes
1
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.
Time frame
Baseline and 3 months2
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.
Time frame
Baseline and 6 weeks3
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.
Time frame
Baseline and 6 weeksSponsors and contacts
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Source ClinicalTrials.gov