| CTRI Number |
CTRI/2024/02/062985 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
descriptive observational study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing rural women’s awareness about urinary incontinence
and factors contributing to the social stigma |
|
Scientific Title of Study
|
Assessing rural women’s awareness about urinary incontinence
and factors contributing to the social stigma An Observational 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 |
Dr Vaidehi vivek kannao |
| Designation |
Master of community physiotherapy student |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15
Physiotherapy Community Department Ambajogai
road Latur MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
7038765139 |
| Fax |
|
| Email |
vaidehi.kannao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shyam jungade |
| Designation |
Associate professor & HOD of community Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15
Physiotherapy Community Department Ambajogai
road Latur MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
9860246678 |
| Fax |
|
| Email |
jshyamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyam Jungade |
| Designation |
Associate professor & HOD of community Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15
Physiotherapy Community Department Ambajogai
road Latur MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
9860246678 |
| Fax |
|
| Email |
jshyamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus
Ambajogai road Latur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Vaidehi Kannao |
Maharashtra Institute of Physiotherapy Latur |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15
Physiotherapy Community Department Ambajogai
road Latur MAHARASHTRA
413512
India
Latur
MAHARASHTRA |
7038765139
vaidehi.kannao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute of Physiotherapy Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1 Patient comfortable to participate
2 Age 21-70years
3 Married women
4 Population around tertiary care center |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient comfortable to participate
2. Age 21-70years
3. Married women
4. Population around tertiary care center |
|
| ExclusionCriteria |
| Details |
1. Not comfortable to participate
2. Hearing deficits
3. Significant cognitive disability or aphasia (incapable of following
the directions of the therapists) or psychiatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| questionnaire |
one time assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
01/03/2024 |
| 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="0"
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
|
The patients with age ranging between 21-70 years will be selected in the study. Participants will be selected on the basis of inclusion and exclusion criteria. The entire procedure will be explained to the subjects. The informed written consent will be taken from the subjects. Subjects comfortable to participate will be taken. Participants will have to answer the questions asked by physiotherapist to complete the questionnaire. It is a self-made questionnaire is used, for which validation is done. It includes sociodemographic, gynecological and obstetric features of the participant, Questions regarding stress urinary incontinence symptoms, to assess knowledge about UI and its forms of treatment, to assess quality of life. Based on the questionnaire analysis will be done. |