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CTRI Number  CTRI/2021/04/033093 [Registered on: 26/04/2021] Trial Registered Prospectively
Last Modified On: 11/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   symptoms and factors affecting pelvic floor in young females 
Scientific Title of Study   THE PROPORTION OF PELVIC FLOOR SYMPTOMS, ASSOCIATED FACTORS AND KNOWLEDGE OF PELVIC FLOOR DYSFUNCTION AMONG LATE ADOLESCENT FEMALE STUDENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalaishree Shankar 
Designation  PG student 
Affiliation  Kasturba Medical College, Mangalore, MAHE 
Address  Kasturba Medical College, Department of Physiotherapy, bejai

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9022755522  
Fax    
Email  ppgkalais@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shyam Krishnan K 
Designation  Assistant Professor- Senior Scale 
Affiliation  Kasturba Medical College 
Address  Kasturba Medical College, Department of Physiotherapy, bejai

Dakshina Kannada
KARNATAKA
575004
India 
Phone  08242422271  
Fax    
Email  krish.shyam@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Kalaishree Shankar 
Designation  PG student 
Affiliation  Kasturba Medical College, Mangalore, MAHE 
Address  Kasturba Medical college, department of Physiotherapy, bejai

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9022755522  
Fax    
Email  ppgkalais@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [] 
 
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 
Kalaishree  Kasturba medical college  Kasturba Medical college department of Physiotherapy Attavar
Dakshina Kannada
KARNATAKA 
09022755522

ppgkalais@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KMC, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pelvic floor dysfunction 
Patients  (1) ICD-10 Condition: N819||Female genital prolapse, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Female 
Details  Nulliparous 
 
ExclusionCriteria 
Details  Multiparous
Diagnosed with neuromuscular, musculoskeletal, systematic conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
find the proportion of pelvic floor symptoms  a year 
 
Secondary Outcome  
Outcome  TimePoints 
associated factors and knowledge of Pelvic floor dysfunction  time bound 
 
Target Sample Size   Total Sample Size="383"
Sample Size from India="383" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="303" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/04/2021 
Date of Study Completion (India) 15/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="22"
Months="3"
Days="23" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   On the basis of inclusion criteria, eligible subjects will be given consent form and will be explained about the purpose of the study and demographic data also will be collected.
The participants will be given three questionnaire to fill by themselves,
1. Pelvic floor bother questionnaire
2. Prolapse and Incontinence Knowledge questionnaire
3. Global physical activity questionnaire
Based on which the severity of the pelvic floor symptoms will be determined
 
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