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临床试验/NCT05253898
NCT05253898Unknown不适用

Comparison of Group-based Pelvic Floor Physical Therapy and Therapeutic Yoga for Postnatal Stress Urinary Incontinence

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
1
主要终点
İncontinence Questionary at 8 weeks

研究概览

简要总结

The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).

详细描述

32 subjects with postnatal stress urinary incontinence will be included in the study after a voluntary consent form will be filled out. Subjects will randomly be divided into two groups according to the order.

Pelvic floor physical therapy (PFT) (n=16) will be Group 1, and therapeutic yoga training (TYT) (n=16) will be the Group 2.

PFT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, pelvic floor muscle contractions in different positions, and abdominal breathing techniques. Each session is planned for 45 minutes.

TYT group will be received sessions twice a week and a special home exercise program once a week for 8 weeks. Each session will include warm-up exercises, different asanas, and yogi breathing exercises. each session is planned for 45 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ages between 18 and 50 years old,
  • Women who have SUI 45 days and above after giving birth
  • Patients who accept to join the group sessions and will participate regularly in the treatment program

排除标准

  • Women who have pelvic organ prolapsus and fecal incontinence
  • Women who have undergone surgery for the lower urinary system
  • Those who receive medication treatment for incontinence in the last 3 months
  • Those with acute infection and bladder stones or tumors will not be included in the study.

结局指标

主要结局

İncontinence Questionary at 8 weeks

时间窗: Change from Baseline in incontinence questionary at 8 weeks

İncontinence Questionary-3 (3IQ) is a simple questionnaire to categorize the type of urinary incontinence. First question evaluates the existence of incontinence in the past 3 months. Second and third questions are directed to familiarity and the existence of the types of incontinence. The 3IQ is a quick test to evaluate the types of urinary incontinence with high sensitivity especially for stress urinary incontinence.

1 hour Pad Test

时间窗: Change from Baseline in Pad Test at 8 weeks

Pad test is an objective way to scale the amount of incontinence in a specific time and the same conditions. The test begins with drinking 500ml water and 30 minutes sitting, then equal repetitions of jumping, walking, coughing, bending down, and washing hands-on running water for each patient.

State-Trait Anxiety Inventory

时间窗: Change from Baseline in State-Trait Anxiety Inventory at 8 weeks

State-Trait Anxiety Inventory (STAI) form consist of 2 different tool. STAI-I examines the current anxiety level, and STAI-II examines the aspects of anxiety proneness general states of calmness and confidence. STAI-I consist of 20 questions about how person feel during the test. STAI-II consist of 20 questions about continues anxiety level.

Bladder Diary

时间窗: Change from Baseline in Bladder Diary at 8 weeks

Bladder diary is used to asses lower urinary tract symptoms (LUTS).

Incontinence Severity Index

时间窗: Change from Baseline in Incontinence Severity Index at 8 weeks

Incontinence Severity Index (ISI) is a tool for assessing the severity of female urinary incontinence. ISI is consists of 2 questions to establish frequency and amount of leakage. The results categorize the severity into 4 as; slight, moderate, severe, and very severe.

Incontinence Quality of Life

时间窗: Change from Baseline in Incontinence Quality of Life at 8 weeks

Incontinence Quality of Life (I-QoL) is used for assessing the decrease of quality of life depending on urinary incontinence symptoms. I-QoL consists of 22 questions and results with 4 domains. I-QoL has identified the 3 factors; avoidance and limiting behavior (8 items), psychosocial impacts (9 items), and social embarrassment (5 items).

Global Perception of Improvement

时间窗: Change from Baseline in Global Perception of Improvement at 8 weeks

Global Perception of Improvement (GPI) is used for showing the individual improvement of healing depending patient's perspective. GPI is rated to the satisfaction of advancement depending on the treatment for patients. Patients rated themselves as much better, better, about the same, worse, and much worse.

Pelvic Floor Muscle Strength assessing with PERFECT

时间窗: Change from Baseline in PERFECT degrees at 8 weeks

PERFECT is used to assess pelvic floor muscle power, endurance, maximal repetitions, and the number of fast contractions by using internal digital palpation. (P) symbolizes the power and this value is identified with modified oxford Scale during max. volunteer contraction. (E) symbolizes the endurance and it's identified by how much time will continue the max. volunteer contraction. (R) symbolizes the repetitions and it's identified with the number of maximum volunteer contractions, between each contraction, must be 4 s resting time. (F) symbolizes the fast and it's identified the number of fast contractions. (ECT) symbolizes every contraction time which means recording all numbers and times during evaluation.

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nergiz Sayın

Principal Investigator

Hasan Kalyoncu University

研究点 (1)

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