| CTRI Number |
CTRI/2025/08/093705 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing a Hindi questionnaire to understand how urinary leakage affects women’s daily life. |
|
Scientific Title of Study
|
Cross-cultural adaptation, translation and psychometric evaluation of the Hindi version of Urinary Impact Questionnaire-7 among women with urinary incontinence: 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 |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jsharmaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh, India-203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Jyoti Sharma |
Galgotias University |
Room no. AI-217, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit,
Sector 17A, Greater Noida, Uttar Pradesh, India-203201
Gautam Buddha Nagar
UTTAR PRADESH |
9717161626
jsharmaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Galgotias University Human Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed with urinary incontinence
Native Hindi speakers
Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Neurological or psychiatric conditions
Current urinary tract infection or recent pelvic surgery
Pregnant or postpartum within 6 weeks
Unable to comprehend Hindi
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urinary Impact Questionnaire-7 |
At baseline and after 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/09/2025 |
| 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="2"
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
|
Urinary incontinence (UI) affects women’s physical, social, and psychological well-being, yet patient-reported outcome measures are limited in Hindi. The Urinary Impact Questionnaire-7 (UIQ-7) is a brief, validated tool for assessing the impact of UI on daily life. This study aims to translate, culturally adapt, and evaluate the psychometric properties of the Hindi UIQ-7 for use among Indian women. A cross-sectional design will recruit adult women with urinary incontinence who can read Hindi. Translation will follow standard forward-backward methods, expert committee review, and pilot testing for clarity and cultural relevance. Reliability (internal consistency and test-retest) and validity (content and construct) will be assessed. The study expects to provide a reliable, culturally appropriate Hindi tool, facilitating better clinical assessment, symptom monitoring, and research in women with urinary incontinence in India. Ethical approval and informed consent will be obtained. |