Effects of Pelvic Floor Rehab Protocol on Urinary Incontinence
2026年7月17日 更新者:Riphah International University
Effects of Pregnancy Specific Pelvic Floor Rehab Protocol on Urinary Incontinence
Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being.
The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups.
The goal of this randomized controlled trial is to compare the effects of pregnancy specific pelvic floor rehab protocol with the standard protocol on urinary incontinence.
Participants will be randomly assigned to one of the two groups.
The results of this trial would be helpful in this way that how Pregnancy specific pelvic floor rehab protocol can provide support for pregnant ladies with urinary incontinence and improve health outcomes.
研究概览
地位
主动,不招人
条件
详细说明
The International Continence Society defines urinary incontinence as the 'unintentional or involuntary leakage of urine'.
Urinary incontinence is a serious health issue that deeply affects a person's daily life and overall well-being.
It can be physically exhausting and emotionally overwhelming, often leading to embarrassment, loss of confidence, and feelings of helplessness.
Many people dealing with it also struggle with anxiety and depression, as it limits their freedom and makes even simple daily tasks feel challenging.
Urinary incontinence (UI) is common during pregnancy with prevalence rates of 31% in nulliparous women and 42% in parous women.
The global prevalence of UI is between 5 to 69% during a woman's lifetime, with higher prevalence in older age groups. .
Urinary incontinence during pregnancy affects women's physical comfort, emotional well-being, and quality of life, yet it remains under-identified and undertreated in standard antenatal care.
Although pelvic floor exercises are widely recommended, most existing programs are not adapted to the unique demands of pregnancy.
A structured, pregnancy-specific pelvic floor rehabilitation protocol can address these needs more effectively by offering trimester-based guidance, functional training, and education. .
This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening.
Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing.
Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
Participants will be randomly assigned through convenient sampling method to each groups.
Ethical considerations will be completely taken and data will be analyzed through SPSS version 26.
This study aims to evaluate the impact of such a protocol and provide evidence to support its integration into routine prenatal care, potentially improving maternal outcomes and long-term recovery.
研究类型
介入性
注册 (估计的)
48
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
-
-
Islamabad
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Islamabad、Islamabad、巴基斯坦、44000
- Riphah International Hospital
-
-
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:
- Pregnant women aged 18-35 yrs.
- Score ≥1 on stress or urge subscale of the Questionnaire for Incontinence Diagnosis
- No participation in a structured pelvic floor rehabilitation program within the last six months.
Exclusion Criteria:
• Patients with High-risk pregnancy.
- Known neurological disorders.
- History of pelvic surgery.
- ACOG Contraindications for Exercise
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Standard Pelvic floor Rehab Protocol Group
This group receives standard protocol for strengthening of pelvic floor to prevent urinary incontinence.
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in this group, standard exercises used for strengthening of pelvic floor to prevent urinary incontinence will be implemented.
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实验性的:Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (2nd Trimester)
This group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education.
There will be 2 sessions per week for 4 weeks.
Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
|
This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening.
Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing.
Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise & 2 sets each.
The record of each session will be written in diaries.
|
|
实验性的:Pregnancy Specific Pelvic floor Rehab Protocol (PSPFR) Group (3rd Trimester)
This group will receive a pregnancy-specific supervised pelvic floor rehabilitation protocol and basic antenatal education.
There will be 2 sessions per week for 4 weeks.
Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
|
This pregnancy-specific pelvic floor rehabilitation protocol follows a progressive 4-week plan focused on pelvic floor muscle training, core activation, and functional strengthening.
Exercises such as Kegels, abdominal drawing-in, bridging, and clamshells are performed in various positions with controlled breathing.
Each 30-minute session, conducted twice weekly, includes a structured warm-up, weekly targeted exercises (Week 1-4), and a cool-down phase for relaxation, flexibility, and bladder/postural education.
The instructions of the supervised exercises would be Hold for 2 s in 3 repetitions, 5 seconds rest, 1 minute of rest between each exercise & 2 sets each.
The record of each session will be written in diaries.
|
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 |
|---|---|---|
|
Questionnaire for Incontinence Diagnosis
大体时间:4 weeks
|
The Questionnaire for Incontinence Diagnosis is a self-reported screening tool used to identify the presence and type of urinary incontinence, such as stress, urge, or mixed incontinence.
It consists of structured questions related to symptom triggers, frequency, and leakage patterns.
Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 (All of the time).
Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 4, 5, and 6 are summed for the Urge score.
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4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incontinence Severity Index
大体时间:4 weeks
|
The ISI is a quick, two-question tool that assesses the frequency and amount of urine leakage.
Scores range from 0 to 12, indicating severity from none to very severe.
It is simple to administer and useful for tracking symptom changes over time.
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4 weeks
|
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International Consultation on Incontinence Questionnaire (ICIQ-UI-SF)
大体时间:4 weeks
|
The ICIQ-UI-SF is a validated self-reported questionnaire that assesses the frequency, severity, and impact of urinary incontinence.
Scores range from 0 to 21, with higher scores indicating greater symptom severity and quality-of-life impact.
It is widely used to quantify the patient-reported burden of incontinence.
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4 weeks
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Incontinence Impact Questionnaire
大体时间:4 weeks
|
The IIQ-7 assesses the psychosocial and functional impact of urinary incontinence on daily life, including physical activity, travel, and emotional well-being.
Scores range from 0 to 100, with higher scores reflecting a greater negative impact.
It is a useful tool for evaluating quality of life related to incontinence.
|
4 weeks
|
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Patient Global Impression of Improvement Scale
大体时间:4 weeks
|
The PGI-I is a single-item scale that captures the patient's overall perception of symptom improvement after treatment.
It reflects subjective satisfaction with the intervention.
The 7-point scale ranges from 1 (very much better) to 7 (very much worse), with lower scores indicating greater improvement.
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4 weeks
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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。
调查人员
- 首席研究员:Dr Zahra Ijaz、Riphah International University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wu Y, Li T, Cai F, Ye X, Xu M. Stable pelvic floor muscle training improves urinary incontinence in women with gestational diabetes mellitus. J Obstet Gynaecol. 2024 Dec;44(1):2420192. doi: 10.1080/01443615.2024.2420192. Epub 2024 Oct 30.
- Kamali S, Ozengin N, Topcuoglu MA. The effect of e-pelvic floor muscle training on symptoms in women with stress urinary incontinence: a randomized controlled trial. Women Health. 2023 Jul 3;63(6):473-483. doi: 10.1080/03630242.2023.2223729. Epub 2023 Jun 14.
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)
2025年11月1日
初级完成 (实际的)
2026年5月7日
研究完成 (估计的)
2026年7月30日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年7月20日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年7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
- Attiya Azhar
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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
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