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临床试验/CTRI/2021/03/032441
CTRI/2021/03/032441尚未招募不适用

“A study to assess the effect of pelvic floor muscle strengthening exercises on urinary incontinence in patients with cervical cancer undergoing radiation therapy at a tertiary cancer center.â€

Tata Memorial Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年5月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To analyze the effect of pelvic floor muscle strengthening exercises on urinary incontinence in patients with cervical cancer undergoing radiation therapy .

研究概览

简要总结

Cervical cancer is a one of the most common and dreaded disease of women in India and 16 % of total cervical cancer occurring  in Globally. The cervical cancer treatment surgery and chemoradiotherapy .Radiation therapy has greater effect on pelvic floor than other treatment because it cause actinic injuries .One of the complication of the radiation therapy is urinary incontinence .Urinary incontinence is not life-threatening disease ,but the loss of bladder control  can affect social ,psychological ,familial ,occupational physical and sexual aspects on the patient lives. Urinary incontinence leads to reduce quality of life ,to cause social isolation and restriction of life style. The Pelvic floor muscle exercises is benefited for treating urinary incontinence by strengthening pelvic floor muscles .also it is economic intervention it improve quality of life of patients and self esteem & confidence of participants .

Research design will be Quasi experimental design -one group pre-test post test design .Tool use in study will be International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF ) and Perineometer to evaluate effect of pelvic floor muscle strengthening exercises on urinary incontinence .Sample size will be 45. Sample will be select on the basis of inclusion  & exclusion criteria .We will explain anatomy of pelvic floor muscle with anatomical model of Pelvic then demonstrate 4 types exercise to participants . total time for exercises require 18-20 min each session, participant will perform exercise 4 time in a day for 8 weeks . With the help of Log book will be maintain patient compliance and records .1st assessment will be on Pre-intervention then second assessment will be on post intervention 8th and 12th weeks of complete  of intervention of each patients . All analysis will be done by SPSS (The statistical package for social sciences )IBM Corp.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Age >18 years and <_65 years cervical cancer.
  • 2.Patient undergoing radiation therapy as NCG guideline.
  • (5 weeks of EBRT + 2 weeks Brachy therapy) 3.Patient receiving concurrent therapy.
  • 4.Patient will be able to follow and perform exercises.

排除标准

  • Patients with bladder involvement .
  • 2.Ptient who have undergone surgery of female reproductive organ.

结局指标

主要结局

To analyze the effect of pelvic floor muscle strengthening exercises on urinary incontinence in patients with cervical cancer undergoing radiation therapy .

时间窗: 1. 1st assessment will be on preintervention (day 0) | 2. 2nd assessment will be on 8th weeks of completion of intervention by each patient. | 3. 3rd assessment will be on 12th weeks of completion of intervention by each patient.

次要结局

  • 1. To find the incidence of urinary incontinence with regard to the clinical data at the time of diagnosis and plan of radiation therapy.
  • 2. To find the association between urinary incontinence with regard to the clinical data(1. 1st assessment will be on preintervention (day 0))

研究者

发起方
Tata Memorial Center
申办方类型
Other [Govt Hospital]

研究点 (1)

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