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临床试验/NCT06088394
NCT06088394招募中不适用

Effect of Pelvic Floor Exercises Versus Pelvic Floor Exercises and Acupuncture on Overactive Bladder

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Modified Oxford scale

研究概览

简要总结

The aim of this study is to investigate the effect of pelvic floor exercises augmented with acupuncture on overactive bladder

详细描述

Overactive bladder syndrome (OAB) is a common complaint affecting 11.8% of the population. OAB is defined by the International Continence Society as "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology."Urinary frequency accompanies OAB in 20%-25% of cases, and nocturia is present in 70%-75% of cases. Around one in three people with OAB also experience urinary incontinence. . OAB can be further categorized into "OAB-dry" (urinary incontinence is absent) and "OAB-wet" (urinary incontinence is present). 2 OAB is a long-term condition that reduces quality of life, leading to anxiety and depression and a negative effect on self-esteem.

Pelvic floor exercises and acupuncture play an important role in overactive bladder.This trial has 2 groupes ,one will recieve pelvic floor exercises augmented with acupuncture ,the second will recive pelvic floor exercises only for 12weeks.

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)

盲法说明

random generator

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients with a clinical diagnosis of idiopathic OAB syndrome. Willingness to take part in the study protocol. Ability to complete outcome measures. Ability to give informed consent. Acupuncture not contra-indicated. Age:50-60 years. Vaginal delivery.
  • •Parity:2-3times. Body mass index <35kg/m2.

排除标准

  • •- Evidence of other pathology that may be contributing to OAB symptoms i.e., urinary tract infection or a neurological condition.
  • •Taking sedative and hypnotic drugs.

研究组 & 干预措施

The patients will do pelvic floor exercises and acupuncture

Experimental

The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks

干预措施: Acupuncture (Device)

The patients will do pelvic floor exercises and acupuncture

Experimental

The patients will perform pelvic floor exercises and acupuncture 3 times per week for 12 weeks

干预措施: pelvic floor exercises (Other)

The patient will do pelvic floor exercises

Experimental

The patient will perform pelvic floor exercises 3 times per week for 12 weeks. pelvic floor muscles exercises involves repetitive contraction and relaxation of the pelvic floor muscles in an attempt to strengthen the muscles .

Each training session involved three training rounds and each round lasted for five minutes. Women will be instructed to perform PFMC and rest with 10min break between each round. They will be instructed to perform two to three sets of PFE repetitions per day, with 8-10 PFMC lasting for 10 s each set. All women will be asked to document their practice of PFE in PFE diary to assess their compliance.

干预措施: pelvic floor exercises (Other)

结局指标

主要结局

Modified Oxford scale

时间窗: 12 weeks

The scale ranges from 0 to 5 ranging from "no contraction" to "maximal contraction which is assessed by digital palpation using 1 to 2 fingers inserted into the vagina or rectum . This method is reliable to assess improvements in overall function and voluntary control of the PFM necessary for proper voiding

次要结局

  • patient perception of intensity and urgency scale (PPIUS)(12 WEEKS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Ahmed Elsayed

principle investigator

Cairo University

研究点 (1)

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