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临床试验/NCT06875778
NCT06875778已完成不适用

Development and Validation of Pregnancy Specific Pelvic Floor Rehab Protocol

Riphah International University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Pelvic Floor Distress Inventory (PFDI)

研究概览

简要总结

Pelvic Floor Weakness is very common Facing by women during Pregnancy. PFM weakness is recognized as one of the problems encountered in patients with urinary and fecal incontinence which have very negative impact on Quality of life of Patients. This project aims to design, implement, and validate a pelvic floor rehabilitation protocol specifically for pregnant individuals.

详细描述

The review of existing literature undergoes the critical need for a pregnancy-specific pelvic floor rehab protocol to address the unique physiological and functional changes experienced during and after pregnancy. While current pelvic floor rehab approaches provide valuable insights, they often lack specific adaptations for the pregnant population, In First Phase of Study the protocol will be developed .The protocol will focus on preventing and managing pelvic floor dysfunction (PFD), such as urinary incontinence, pelvic organ prolapse, and pelvic pain, which are common during pregnancy. The program will incorporate evidence-based exercises, education, and lifestyle modifications, ensuring it is safe, effective, and adaptable to pregnancy.

In Second Phase it will be validated and Pilot testing will be done.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •diagnosed pelvic floor dysfunction. Female participants experience pelvic floor symptoms such as incontinence, pelvic pain, or prolapse.
  • •No previous participation in a structured pelvic floor rehabilitation program within the last six months

排除标准

  • •Pregnant women or those planning to become pregnant during the study period.
  • •Patients with neurological disorders affecting pelvic floor function (e.g., multiple sclerosis, spinal cord injury).
  • •Individuals with severe psychiatric conditions that might interfere with participation.
  • •Recent pelvic surgery within the last three months.
  • •Any contraindications to physical therapy or specific exercises included in the rehab program.

研究组 & 干预措施

Pelvic Floor Rehab Group

Experimental

This Group will receive a developed Pelvic floor exercises protocol for 4 Weeks

干预措施: Pelvic Floor Exercises (Other)

结局指标

主要结局

Pelvic Floor Distress Inventory (PFDI)

时间窗: Baseline to 4th Week

The PFDI-20 questionnaire is designed to evaluate symptoms and quality of life relating to PFDs; it has 20 items and three scales for three different symptoms to assess symptoms of distress from UI (Urinary Distress Inventory-6), POP (Pelvic Organ Prolapse Distress Inventory-6), and defecatory dysfunction (Colo rectal-Anal Distress Inventory-8). By adding three subscales the score ranges from 0-300. The higher the score the greater the perceived impact that pelvic floor dysfunction has on a patient's life.

Pelvic Floor Muscle Strength Assessment through MMT-oxford scale

时间窗: Baseline to 4th Week

The grading system used to determine the strength of the pelvic floor muscles is the Oxford Scale or Modified Oxford Scale. It is a subjective grading system used to assess the strength and quality of contraction of the pelvic floor muscles. The muscles will be assessed via an external vaginal examination. Score Ranges from 0-5 . higher score indicate better muscle strength.

Pelvic Floor Impact Questionnaire (PFQI)

时间窗: Baseline to 4th Week

The pelvic floor impact questionnaire was designed to evaluate symptoms and quality of life relating to PFDs; it included scales from the Urinary Impact Questionnaire. (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire (POPIQ), Colorectal - Anal Impact Questionnaire -7(CRAIQ-7). All items use the following format with the response scale ranging from (0 to 3). Add the scores from the 3 scales together to obtain the summary score (range 0-300). Lower scores indicate less effect on QOL.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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