| CTRI Number |
CTRI/2025/08/093676 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation and testing of a Hindi questionnaire to assess pelvic area weakness in Indian women |
|
Scientific Title of Study
|
Cross-cultural adaptation, translation and psychometric evaluation of the Hindi version of Pelvic Floor Distress Inventory-Short Form 20 in Indian Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jyoti.sharma@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201310
UTTAR PRADESH
201310
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jyoti.sharma@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Sharma |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University, Sector 17A, Opp. Yamuna Expressway, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 201310
UTTAR PRADESH
201310
India |
| Phone |
9717161626 |
| Fax |
|
| Email |
jyoti.sharma@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
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 |
Room no. AI-217, Department of Physiotherapy, SAHS, Galgotias University |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9717161626
jyoti.sharma@galgotiasuniversity.edu.in |
|
|
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 |
| Healthy Human Volunteers |
None |
|
|
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 |
Women diagnosed with pelvic floor disorders
Native Hindi speakers
Able and willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Presence of neurological or psychiatric disorders
Pregnancy or postpartum within 6 weeks
Illiteracy or inability to comprehend the questionnaire
Acute infections or recent pelvic surgeries of more than three months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic Floor Distress Inventory-Short Form 20 |
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
|
Pelvic floor disorders (PFDs), including urinary incontinence and pelvic organ prolapse, significantly impact women’s quality of life. The Pelvic Floor Distress Inventory–Short Form 20 (PFDI-SF 20) is a validated patient-reported outcome measure internationally, but no Hindi version exists. This study aims to translate, culturally adapt, and evaluate the psychometric properties of the Hindi PFDI-SF 20 for use in Indian women. A cross-sectional design will be used, recruiting adult women with pelvic floor symptoms who understand Hindi. Translation will follow standard forward-backward methods and expert committee review. Reliability (internal consistency and test-retest) and validity (content and construct) will be assessed. The study will provide a reliable and culturally relevant Hindi tool for assessing pelvic floor distress, enabling better clinical evaluation, monitoring, and research in Indian women. Ethical approval and informed consent will be obtained. |