A study to assess the effect of pelvic floor exercises for urinary incontinence in patients with cervical cancer receiving radiation therapy .

Not yet recruiting

Conditions: Malignant neoplasm of overlappingsites of cervix uteri,

Registration Number: CTRI/2021/03/032441

Lead Sponsor: Tata Memorial Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 45

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1): Tata memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Prathepa Jagdish
Principal investigator
9869220441
prathepa_jagadish@rediffmail.com