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CTRI Number  CTRI/2021/03/032441 [Registered on: 31/03/2021] Trial Registered Prospectively
Last Modified On: 30/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the effect of pelvic floor exercises for urinary incontinence in patients with cervical cancer receiving radiation therapy .  
Scientific Title of Study   “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.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
3662 version 3.0 date 24/2/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prathepa Jagadish 
Designation  Associate Professor  
Affiliation  Tata Memorial Hospital  
Address  Room No.1 , 13th floor, Nursing Education Department, HomiBhabha Building , Mumbai
Room No.1 , 13th floor, Nursing Education Department, HomiBhabha Building , Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9869220441  
Fax  022-24146937  
Email  prathepa_jagadish@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Prathepa Jagadish 
Designation  Associate Professor  
Affiliation  Tata Memorial Hospital  
Address  Room No.1 , 13th floor, Nursing Education Department, HomiBhabha Building , Mumbai
Room No.1 , 13th floor, Nursing Education Department, HomiBhabha Building , Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9869220441  
Fax  022-24146937  
Email  prathepa_jagadish@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  shilpa Sakharam Bhosale 
Designation  M.Sc. Nursing student  
Affiliation  Tata Memorial Hospital  
Address  Room No.1 , 13th floor, Nursing Education Department, HomiBhabha Building , Mumbai
Room No.1 , 13th floor, Nursing Education Department, HomiBhabha Building , Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9892934759  
Fax    
Email  shilpasbhosale89@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital ,Dr. Borges road Parel,Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Center  
Address  Tata Memorial Center , Parel , Mumbai-400012 Maharashtra ,India . 
Type of Sponsor  Other [Govt Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prathepa Jagdish   Tata memorial Hospital   OPD no 52 ,ground floor ,Homi Bhabha Building ,Tata Memorial Hospital Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9869220441
022-24146937
prathepa_jagadish@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee ,IEC-I Tata Memorial Hospital Mumbai,  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C538||Malignant neoplasm of overlappingsites of cervix uteri,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Pelvic floor muscle strengthening Exercises   pelvic floor muscle strengthening exercise consist of 4 exercises a)Kegel exercise b)Squeeze and release c)Pelvic floor /inner thigh ball squeeze d)Lower trunk rotation /Lying hip rotation Total time required for each session 18-20 min Patient will be perform exercise 4 time a day From at the time of simulation (day O ) to 12 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. 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.




 
 
ExclusionCriteria 
Details  1. Patients with bladder involvement .

2.Ptient who have undergone surgery of female reproductive organ.

3.Patient who are mentally unsound .



 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
1. To find the incidence of urinary incontinence with regard to the clinical data at the time of diagnosis and plan of radiation therapy.
 		 1. 1st assessment will be on preintervention (day 0)
. 
2. To find the association between urinary incontinence with regard to the clinical data  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 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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