盆底肌训练联合或不联合体外磁神经调控治疗早泄
2026年9月9日 更新者：Fatih UYSAL、Abant Izzet Baysal University
一项单中心前瞻性干预研究：比较单纯盆底肌训练与联合体外磁神经刺激治疗男性早泄的效果
这是一项单中心、前瞻性干预研究，比较单纯盆底肌训练（PFMT）与PFMT联合体外磁刺激（ExMI）在早泄（PE）男性中的效果。
研究目的是确定在标准PFMT基础上增加ExMI是否能改善盆底功能和患者报告的性生活质量。
研究概览
地位
完全的
详细说明
这是一项单中心、前瞻性干预研究，前瞻性评估了两种非药物方法治疗早泄（PE）：单独进行盆底肌肉训练（PFMT）与PFMT联合体外磁刺激（ExMI）的比较。 成年男性患者，经临床诊断为PE，在一家大学医院的物理治疗/泌尿科门诊入组，并在8周的干预期内进行随访。 该试验为开放标签、平行分组设计；参与者接受了临床实践中使用的治疗（仅PFMT或PFMT+ExMI），并根据预定义方案前瞻性收集结果。
PE很常见且损害生活质量。 PFMT可能改善盆底的神经肌肉控制，而ExMI通过基于椅子的磁刺激激活盆底肌肉组织。 我们假设，在标准PFMT基础上添加ExMI，会比单独使用PFMT在盆底功能和患者报告的性功能结果方面产生更大的改善。
所有参与者均接受了结构化教育和一项渐进的、家庭为基础的PFMT计划，在8周期间接受监督。 PFMT+ExMI组还接受了基于椅子的磁刺激，按照诊所针对盆底肌肉的预定义方案进行。
评估在基线时和干预后（第8周）进行，并在可行的情况下进行短期随访。 主要结局是通过标准化指令下实时耻骨上超声测量的盆底肌肉位移距离和耐力。 次要结局包括早泄诊断工具（PEDT）、国际勃起功能指数（IIEF-5）、男性性功能问卷简表（MSFI-SF）、世界卫生组织生活质量简表（WHOQOL-BREF）性满意度条目、整体感知效果以及安全性/不良事件。
研究类型
介入性
注册 (实际的)
44
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Merkez
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Bolu、Merkez、土耳其（türkiye）、14030
- Bolu Abant Izzet Baysal University, Faculty of Health Sciences
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 男性，25-45岁，有性行为
- 经专科医生临床诊断为早泄
- 能够配合盆底肌训练和评估
- 完成基线临床/超声记录
排除标准：
- 神经系统疾病（如多发性硬化症）
- 影响结局的代谢/全身/精神疾病
- 显著心血管疾病
- 影响勃起/射精的药物
- 慢性前列腺炎/尿道炎或活动性尿路感染
- 佩罗尼病或基线时已有阴茎假体
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Arm A - Pelvic Floor Muscle Training (PFMT)
Participants received structured education about pelvic floor anatomy and function and completed an 8-week progressive home-based pelvic floor muscle training program.
The program included both slow and fast pelvic floor muscle contractions performed in five sets daily.
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Participants performed five sets of pelvic floor muscle exercises daily for 8 weeks.
Each set included slow and fast contractions.
The number of each type of contraction was progressively increased from 10 in week 1, to 20 in week 2, 30 in week 3, and 40 in week 4.
During weeks 5-8, each set included 50 slow and 50 fast contractions.
Correct pelvic floor contraction was taught and verified using real-time ultrasonography.
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实验性的：Arm B - Pelvic Floor Muscle Training (PFMT) + Extracorporeal Magnetic Innervation (ExMI)
Participants completed the same 8-week progressive pelvic floor muscle training program as Arm A and additionally received chair-based extracorporeal magnetic innervation twice weekly for 8 weeks, for a total of 16 sessions.
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Participants performed five sets of pelvic floor muscle exercises daily for 8 weeks.
Each set included slow and fast contractions.
The number of each type of contraction was progressively increased from 10 in week 1, to 20 in week 2, 30 in week 3, and 40 in week 4.
During weeks 5-8, each set included 50 slow and 50 fast contractions.
Correct pelvic floor contraction was taught and verified using real-time ultrasonography.
Extracorporeal magnetic innervation was delivered using the EMD E-6000 MAGTHER system with the participant seated on the treatment chair.
Treatment was administered twice weekly for 8 weeks, for a total of 16 sessions.
Each session consisted of 10 minutes of intermittent stimulation at 10 Hz, followed by a 1-minute rest period and 10 minutes of intermittent stimulation at 50 Hz.
Stimulation intensity was increased to the highest comfortably tolerated level.
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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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Pelvic Floor Muscle Displacement (mm) Assessed by Real-Time Suprapubic Ultrasonography
大体时间：Baseline, Week 4, and Week 8
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Pelvic floor muscle activation was assessed by measuring displacement of the caudal border of the prostate from rest to maximal voluntary pelvic floor contraction using real-time suprapubic ultrasonography.
Three contractions were recorded and averaged.
Greater displacement indicates greater pelvic floor muscle activation.
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Baseline, Week 4, and Week 8
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Pelvic floor muscle endurance (seconds) on real-time suprapubic ultrasonography
大体时间：Baseline, Week 4 and Week 8
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Pelvic floor muscle endurance was defined as the duration, in seconds, for which the participant could maintain maximal visible pelvic floor elevation during voluntary contraction under real-time suprapubic ultrasonography.
Longer duration indicates greater pelvic floor muscle endurance.
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Baseline, Week 4 and Week 8
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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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Premature Ejaculation Diagnostic Tool (PEDT)
大体时间：Baseline, Week 4 and Week 8
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The Premature Ejaculation Diagnostic Tool (PEDT) is a 5-item patient-reported questionnaire assessing ejaculatory control, frequency, minimal stimulation, distress, and interpersonal difficulty related to premature ejaculation.
Total scores range from 0 to 20, with higher scores indicating more severe premature ejaculation symptoms.
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Baseline, Week 4 and Week 8
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Brief Sexual Function Inventory (BSFI)
大体时间：Baseline, Week 4 and Week 8
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The Brief Sexual Function Inventory (BSFI) assesses male sexual function across domains including sexual drive, erection, ejaculation, problem assessment, and overall satisfaction.
The total score used in this study ranges from 0 to 44, with higher scores indicating better sexual function.
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Baseline, Week 4 and Week 8
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Five-Item International Index of Erectile Function (IIEF-5)
大体时间：Baseline, Week 4 and Week 8
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The five-item International Index of Erectile Function (IIEF-5) assesses erectile function.
Total scores range from 5 to 25, with higher scores indicating better erectile function.
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Baseline, Week 4 and Week 8
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World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score
大体时间：Baseline, Week 4 and Week 8
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The World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a 26-item questionnaire assessing perceived quality of life.
In this study, the raw total score across all 26 items was used.
Possible total scores range from 26 to 130, with higher scores indicating better quality of life.
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Baseline, Week 4 and Week 8
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Exploratory WHOQOL-BREF Sexual Satisfaction Item
大体时间：Baseline, Week 4, and Week 8
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Sexual satisfaction was assessed using the sexual satisfaction item of the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF).
The item is scored from 1 to 5, with higher scores indicating greater satisfaction with sexual life.
This item was analysed as an exploratory outcome.
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Baseline, Week 4, and Week 8
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Global Perceived Effect Scale (GPES)
大体时间：at Week 8
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The Global Perceived Effect Scale (GPES) assessed the participant's perceived overall improvement following treatment.
Participants rated their perceived improvement on a scale from 0 to 10, where 0 indicated no improvement and 10 indicated satisfactory/maximal perceived improvement.
Higher scores indicate greater perceived improvement.
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at Week 8
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年10月14日
初级完成 (实际的)
2023年2月8日
研究完成 (实际的)
2023年3月8日
研究注册日期
首次提交
2026年1月27日
首先提交符合 QC 标准的
2026年1月27日
首次发布 (实际的)
2026年2月4日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- AIBU-FTR-MFU-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no plan for public sharing of individual participant data.
The original informed consent and ethics approval did not include public deposition of participant-level data.
De-identified data may be considered for sharing on reasonable request, subject to institutional and ethical requirements.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.