| CTRI Number |
CTRI/2025/07/090462 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation of Urinary Incontinence Awareness and Attitude scale from English to Kannada language study. |
|
Scientific Title of Study
|
Cross Culture Adaptation of Urinary Incontinence awareness and attitude scale into Kannada Language A-Reliability and validity 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 |
Tejaswini M |
| Designation |
Master of Physiotherapy |
| Affiliation |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
R L Jalappa College Of Physiotherapy, Department of Physiotherapy, Sri Devaraj Urs Academy Of Higher Education And Research, Tamaka, Kolar, Karnataka.
Kolar KARNATAKA 563103 India |
| Phone |
9980425320 |
| Fax |
|
| Email |
tejuashwini766@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Ranjith Anumasa |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
R L Jalappa College Of Physiotherapy, Department of Physiotherapy, Sri Devaraj Urs Academy Of Higher Education And Research, Tamaka, Kolar, Karnataka.
Kolar KARNATAKA 563103 India |
| Phone |
7204619136 |
| Fax |
|
| Email |
ranjithanumasa.C3276@sduaher.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Mr Ranjith Anumasa |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
R L Jalappa College Of Physiotherapy, Department of Physiotherapy, Sri Devaraj Urs Academy Of Higher Education And Research, Tamaka, Kolar, Karnataka.
Kolar KARNATAKA 563103 India |
| Phone |
7204619136 |
| Fax |
|
| Email |
ranjithanumasa.C3276@sduaher.ac.in |
|
|
Source of Monetary or Material Support
|
| R L Jalappa College Of Physiotherapy, Sri Devaraj Urs Academy Of Higher Education And Research,Tamaka, Kolar, Karnataka, India, 563103 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy Of Higher Education And Research |
| Address |
R L Jalappa College Of Physiotherapy, Sri Devaraj Urs Academy Of Higher Education And Research,Tamaka, Kolar, Karnataka, India, 563103 |
| Type of Sponsor |
Other [Deemed To Be University.] |
|
|
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 Ranjith Anumasa |
R L Jalappa Hospital. |
R L Jalappa College Of Physiotherapy, Department of Physiotherapy, Sri Devaraj Urs Academy Of Higher Education And Research, Tamaka, Kolar, Karnataka,563103. Kolar KARNATAKA |
7204619136
ranjithanumasa.C3276@sduaher.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Academy Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Urinary Incontinence Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females.
Those who know to read Kannada language.
Participants has NO history of Urinary Incontinence. |
|
| ExclusionCriteria |
| Details |
Participants who are already diagnosed with Urinary Incontinence. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To translate English version of URINAS scale into Kannada Language.
To study psychometric properties of Kannada version of URINARY INCONTINENCE AWARENESS AND ATTITUDE Scale. |
Single time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
20/07/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is titled Cross Culture Adaptation of Urinary Incontinence Awareness and Attitude Scale into Kannada Language A Reliability and Validity Study. It is being conducted by Ms. Tejaswini M as the Principal Investigator, with Dr. Ranjith Anumasa and Mr. Likith Manjunath as Co Investigators. The primary purpose of the study is to translate the English version of the Urinary Incontinence Awareness and Attitude Scale URINAS into the Kannada language and to evaluate its psychometric properties, specifically reliability and validity. An additional objective was added regarding copyrights. Urinary Incontinence is a common and often under-reported health issue in India, with prevalence ranging from 10 percentage in rural areas to 34 percentage in urban areas, significantly impacting an individuals quality of life. Studies indicate low awareness of UI, leading individuals to cope with the problem themselves rather than seeking professional help. Given that Kannada speakers number around 40.6 million in Karnataka, there is a need for a culturally adapted and linguistically valid Kannada version of the URINAS scale to assess awareness and attitude towards UI. The study is a cross cultural adaptation study with a duration of one year, taking place at R L Jalappa Hospital, Tamaka, Kolar. It aims to recruit 60 participants aged 18 to 64 years, including both males and females, who can read Kannada and have no history of Urinary Incontinence. Participants already diagnosed with UI will be excluded. The methodology involves a detailed translation and adaptation process - Permission from the original scale developer is obtained.
- Forward translation involves two independent Kannada translations by a General Physician and a Physical Therapist.
- These translations are then synthesized into a common version.
- Backward translation is performed by two native English translators who are not from a medical background and are blinded to the original scale.
- A subsequent synthesis phase compares the back translated version with the original URINAS scale, with verification from the original author, and modifications are made for cultural context.
- An Expert Committee consisting of methodological, health, language professionals, and translators will develop the pre final URINAS K, ensuring its understandability, vocabulary, and relevance for Kannada culture.
After the adaptation, the URINAS K will be administered to 60 participants recruited via convenient sampling. Data will be analysed using SPSS 23. Content validity will be determined using the Content Validity Index, while reliability will be assessed using parallel form testing and internal consistency Cronbach alpha. Construct validity will be evaluated through explanatory and confirmatory factor analysis. All investigations related to the study will be free of cost to the participants. Participation is entirely voluntary, and confidentiality of information will be maintained. The expected benefit is the ability to assess individuals awareness and attitude about UI, which can help them report their condition to healthcare professionals and seek appropriate treatment. |