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
|
|
Primary Sponsor
|
Name |
nil |
Address |
nil |
Type of Sponsor |
Other [] |
|
Details of Secondary Sponsor
|
|
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
|
|
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
|
|
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 |