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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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