| CTRI Number |
CTRI/2024/03/063727 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out the the number of college going females getting affected by leakage of urine and its impact on their quality of life |
|
Scientific Title of Study
|
Prevalence of Urinary Incontinence and its impact on Quality of Life among college going females – A Cross-Sectional Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Thakur |
| Designation |
BPT |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Sola
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7807341872 |
| Fax |
|
| Email |
dikshagautam00726@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arushi Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan |
|
|
Primary Sponsor
|
| Name |
Diksha Thakur |
| Address |
Maharishi Markandeshwar Medical
College and Hospital, Kumarhatti Solan |
| 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 |
| Diksha Thakur |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan |
Room no. 510, 2nd floor, Department of Physiotherapy Maharishi Markandeshwar Medical College and Hospital, Kumarhatti Solan
Solan
HIMACHAL PRADESH |
7807341872
dikshagautam00726@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Urinary Incontinence |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Females from the age group of 18-25 years
College going females
Unmarried females
|
|
| ExclusionCriteria |
| Details |
Pregnant women
Had any genitourinary infections (Urinary tract infection)
Any neurological disorder, psychological disorder
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quid Questionnaire |
One time measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incontinence Impact Questionnaire,Short Form(IIQ-7) |
One time measurement |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
20/03/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
UI is a serious gynaecological condition which is affecting both young and elderly female on larger scale. Due to lack of awareness about gynaecological conditions, they didn’t consider this issue as a medical condition. UI have greater impact on the quality of life of women and can lead to various consequences that is why it is necessary to find out the prevalence rate of UI in young females and to formulating early prevention strategies and interventions. |