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
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hany F Badawy, MD
- Numer telefonu: +201149525028
- E-mail: HANYFATHY86@GMAIL.COM
Kopia zapasowa kontaktu do badania
- Nazwa: Mohamed I Elmaadawy, MD
- Numer telefonu: +201060245430
- E-mail: Mohamed.elmaadawy@med.tanta.edu.eg
Lokalizacje studiów
-
-
Tanta
-
Tanta, Tanta, Egipt
- Rekrutacyjny
- Department of Urology- Tanra University Hospitals
-
Kontakt:
- Mohamed I Elmaadawy, MD
- Numer telefonu: +201060245430
- E-mail: Mohamed.elmaadawy@med.tanta.edu.eg
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
|
Aktywny komparator: 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.
|
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.
|
|
Aktywny komparator: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
Ramy czasowe: 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.
|
Baseline and 6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Intravaginal Ejaculatory Latency Time at 3 Months
Ramy czasowe: 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.
|
Baseline and 3 months
|
|
Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks
Ramy czasowe: 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.
|
Baseline and 6 weeks
|
|
Change in Patient-Reported Ejaculatory Control at 6 Weeks
Ramy czasowe: 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.
|
Baseline and 6 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Mohamed I Elmaadawy, MD, Tanta University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PEPFMT36265PR25426
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .