Effectiveness of Biofeedback-Assisted Pelvic Floor Muscle Training on Sexual Function and Quality of Life in Patient After Hysterectomy
2026年8月20日 更新者：Rana Hosny Abd Elhamid Ghazy、Kafrelsheikh University
The purpose of this study is to determine the effectiveness of biofeedback-assisted pelvic floor muscle training in improving pelvic floor muscle strength, decreasing urinary incontinence symptoms, reducing genital prolaps and enhancing the quality of life in women after hysterectomy.
研究概览
地位
招聘中
详细说明
Hysterectomy, the surgical removal of the uterus, remains one of the most frequently performed gynecological procedures worldwide, indicated for both malignant and benign conditions.
Pelvic floor dysfunction (PFD) is a common complication after hysterectomy, manifesting as urinary incontinence, pelvic organ prolapse, and colorectal symptoms.
Conventional pelvic floor rehabilitation focuses on pelvic floor muscle training (PFMT), widely known as Kegel exercises, to strengthen weakened muscles and improve continence.
研究类型
介入性
注册 (估计的)
70
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。
学习联系方式
- 姓名：Rana H Ghazy, B.Sc
- 电话号码：00201024554438
- 邮箱：ranahosny1196@gmail.com
学习地点
-
-
Kafrelsheikh
-
Kafr ash Shaykh、Kafrelsheikh、埃及、33516
- 招聘中
- Kafrelsheikh University (Faculty of Physical Therapy)
-
接触：
- Rana H Ghazy, B.Sc
- 电话号码：00201024554438
- 邮箱：ranahosny1196@gmail.com
-
-
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
接受健康志愿者
不
描述
Inclusion Criteria:
- Women aged 45-50 years.
- Body Mass Index (BMI) within the range of 18.5 to 29.9 kg/m².
- History of total or subtotal hysterectomy for benign conditions within the past 6 months.
- Abdominal hysterectomy.
- Women have menstrual cycle.
- Presenting with at least one symptom of pelvic floor dysfunction (e.g., stress urinary incontinence and genital prolapse).
- Willing to participate and provide informed consent.
Exclusion Criteria:
- Hysterectomy performed for malignant conditions.
- Prior pelvic floor rehabilitation.
- Neurological disorders affecting muscle control.
- Pelvic infection or current urinary tract infection (UTI).
- Inability to follow instructions or adhere to the program.
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 |
|---|---|
|
实验性的：Group A
Participants will undergo standard post hysterectomy care protocol with electromyographic (EMG)-based biofeedback guidance, using a vaginal sensor to provide real-time visual and/or auditory feedback on pelvic floor muscles contractions.
|
Participants will undergo standard post hysterectomy care protocol with electromyographic (EMG)-based biofeedback guidance, using a vaginal sensor to provide real-time visual and/or auditory feedback on pelvic floor muscles contractions.
|
|
有源比较器：Group B
Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
|
Participants will perform undergo standard post hysterectomy core protocol without biofeedback assistance.
|
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 |
|---|---|---|
|
Female Sexual Function Index (FSFI)
大体时间：12 weeks of intervention
|
Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated 19-item questionnaire evaluating six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
The total FSFI score ranges from 2 to 36, with higher scores indicating better sexual function.
The change in total FSFI score from baseline to the end of the 12-week intervention will be compared between the two study groups.
|
12 weeks of intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pelvic Floor Muscle Strength
大体时间：12 weeks of intervention
|
Pelvic floor muscle strength will be assessed using an electromyographic (EMG)-based biofeedback device with an intravaginal sensor.
Peak EMG amplitude during maximal voluntary pelvic floor muscle contractions will be recorded as an objective measure of pelvic floor muscle strength.
The change from baseline to the end of the 12-week intervention will be compared between the two study groups.
|
12 weeks of intervention
|
|
Urinary Incontinence Severity
大体时间：12 weeks of intervention
|
Urinary incontinence severity will be assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
The questionnaire evaluates the frequency and severity of urinary leakage and its impact on daily life.
Total scores range from 0 to 21, with higher scores indicating greater severity.
The change in ICIQ-UI SF score from baseline to the end of the 12-week intervention will be compared between the two study groups.
|
12 weeks of intervention
|
|
Pelvic Floor-Related Quality of Life
大体时间：12 weeks of intervention
|
Pelvic floor-related quality of life will be assessed using the Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7).
The questionnaire assesses the impact of urinary, colorectal, and pelvic organ prolapse symptoms on daily activities and quality of life.
Scores range from 0 to 300, with higher scores indicating greater negative impact on quality of life.
The change in PFIQ-7 score from baseline to the end of the 12-week intervention will be compared between the two study groups.
|
12 weeks of intervention
|
|
Pelvic Organ Prolapse Severity
大体时间：12 weeks of intervention
|
Pelvic organ prolapse severity will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.
POP-Q measurements will be performed at baseline and after the 12-week intervention to objectively assess changes in pelvic organ support and prolapse stage.
Changes in POP-Q measurements and prolapse stage will be compared between the two study groups.
|
12 weeks of intervention
|
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)
2026年1月1日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年10月1日
研究注册日期
首次提交
2026年8月20日
首先提交符合 QC 标准的
2026年8月20日
首次发布 (实际的)
2026年8月25日
研究记录更新
最后更新发布 (实际的)
2026年8月25日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享时间框架
After the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
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.