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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Hany F Badawy, MD
- 电话号码:+201149525028
- 邮箱:HANYFATHY86@GMAIL.COM
研究联系人备份
- 姓名:Mohamed I Elmaadawy, MD
- 电话号码:+201060245430
- 邮箱:Mohamed.elmaadawy@med.tanta.edu.eg
学习地点
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Tanta
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Tanta、Tanta、埃及
- 招聘中
- Department of Urology- Tanra University Hospitals
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接触:
- Mohamed I Elmaadawy, MD
- 电话号码:+201060245430
- 邮箱:Mohamed.elmaadawy@med.tanta.edu.eg
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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有源比较器: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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有源比较器: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Intravaginal Ejaculatory Latency Time at 6 Weeks
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Intravaginal Ejaculatory Latency Time at 3 Months
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Mohamed I Elmaadawy, MD、Tanta University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PEPFMT36265PR25426
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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