Lifelong Premature Ejaculation, Male Sexual Dysfunction, Premature Ejaculation
Conditions
Keywords
Pelvic floor muscle training, Biofeedback, Electromagnetic pelvic floor stimulation
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.
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.
Interventions
DEVICEElectromagnetic 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.
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.
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intravaginal Ejaculatory Latency Time at 6 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intravaginal Ejaculatory Latency Time at 3 Months | 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. |
| Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks | 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. |
| Change in Patient-Reported Ejaculatory Control at 6 Weeks | 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. |
Countries
Egypt
Contacts
CONTACTMohamed I Elmaadawy, MD
CONTACTHany F Badawy, MD
PRINCIPAL_INVESTIGATORMohamed I Elmaadawy, MD
Tanta University
Outcome results
None listed