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

30. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
    • Tanta
      • Tanta, Tanta, Egypten

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Aktiv 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.
Adfærdsmæssigt: 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.
Aktiv 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Intravaginal Ejaculatory Latency Time at 3 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanta University

Efterforskere

  • Ledende efterforsker: Mohamed I Elmaadawy, MD, Tanta University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. april 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

30. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PEPFMT36265PR25426

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med For tidlig ejakulation

Kliniske forsøg med Electromagnetic Pelvic Floor Stimulation

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