Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Pelvic Floor Therapies for Lifelong Premature Ejaculation (PE-PFMT)

30 mai 2026 mis à jour par: Mohamed Ibrahim Ahmed Elmaadawy, Tanta University

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Egypte
    • Tanta
      • Tanta, Tanta, Egypte
        • Recrutement
        • Department of Urology- Tanra University Hospitals
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: Electromagnetic 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.
Comparateur actif: 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.
Comportemental: Biofeedback-Assisted Pelvic Floor Muscle Training
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.
Comparateur actif: 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.
Comportemental: Conventional Pelvic Floor Muscle Training
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Intravaginal Ejaculatory Latency Time at 3 Months
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tanta University

Les enquêteurs

  • Chercheur principal: Mohamed I Elmaadawy, MD, Tanta University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 avril 2026

Achèvement primaire (Estimé)

1 mars 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

30 mai 2026

Première soumission répondant aux critères de contrôle qualité

30 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PEPFMT36265PR25426

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared because the study involves sensitive individual-level sexual health data. Results will be reported only in aggregated, de-identified form. Any future sharing of anonymized data would require additional ethics committee approval and compliance with participant consent and institutional regulations.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner