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
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Hany F Badawy, MD
- Número de telefone: +201149525028
- E-mail: HANYFATHY86@GMAIL.COM
Estude backup de contato
- Nome: Mohamed I Elmaadawy, MD
- Número de telefone: +201060245430
- E-mail: Mohamed.elmaadawy@med.tanta.edu.eg
Locais de estudo
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Tanta
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Tanta, Tanta, Egito
- Recrutamento
- Department of Urology- Tanra University Hospitals
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Contato:
- Mohamed I Elmaadawy, MD
- Número de telefone: +201060245430
- E-mail: Mohamed.elmaadawy@med.tanta.edu.eg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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.
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Comparador Ativo: 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.
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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.
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Comparador Ativo: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
Prazo: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Intravaginal Ejaculatory Latency Time at 3 Months
Prazo: Baseline and 3 months
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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.
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Baseline and 3 months
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Change in Premature Ejaculation Diagnostic Tool Score at 6 Weeks
Prazo: Baseline and 6 weeks
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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.
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Baseline and 6 weeks
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Change in Patient-Reported Ejaculatory Control at 6 Weeks
Prazo: Baseline and 6 weeks
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Patient-reported ejaculatory control will be assessed using a Likert scale.
The outcome will be expressed as the change from baseline to 6 weeks.
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Baseline and 6 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed I Elmaadawy, MD, Tanta University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PEPFMT36265PR25426
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