FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050754 [Registered on: 16/03/2023] Trial Registered Prospectively
Last Modified On: 10/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective questionaire based study 
Study Design  Other 
Public Title of Study   All women attending gynaecological OPDs will be given a questionnaire for screening for Urinary Incontinence and then will be evaluated further. The participants will then be asked for history and will undergo physical examination.Both subjective and objective scores are compared with each other.  
Scientific Title of Study   Comparison of subjective and objective domains of Stress Incontinence Combined Score (SICS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratyusha Anumolu 
Designation  Junior Resident(1 st year) 
Affiliation  Kasturba Medical College,Manipal 
Address  Kasturba Medical College,Tiger Circle Road, Madhav Nagar, Manipal, Karnataka ,576104
703,A wing,Shambavi sovereign,Vidyarathna nagar Nagar, Manipal, Karnataka ,576104
Udupi
KARNATAKA
576104
India 
Phone  9676219999  
Fax    
Email  pratyusha19955@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deeksha Pandey 
Designation  Additional Professor(OBGYN) 
Affiliation  Kasturba Medical College,Manipal 
Address  Kasturba Medical College,Tiger Circle Road, Madhav Nagar, Manipal, Karnataka ,576104
703,A wing,Shambavi sovereign,Vidyarathna nagar Nagar, Manipal, Karnataka ,576104
Udupi
KARNATAKA
576104
India 
Phone  9241216016  
Fax    
Email  deekshiiiobg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratyusha Anumolu 
Designation  Junior Resident(1 st year) 
Affiliation  Kasturba Medical College,Manipal 
Address  Kasturba Medical College,Tiger Circle Road, Madhav Nagar, Manipal, Karnataka ,576104
703,A wing,Shambavi sovereign,Vidyarathna nagar Nagar, Manipal, Karnataka ,576104
Udupi
KARNATAKA
576104
India 
Phone  9676219999  
Fax    
Email  pratyusha19955@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Pratyusha Anunolu 
Address  KMC,Manipal 
Type of Sponsor  Other [self] 
 
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 
DrPratyusha Anumolu  Kmc,Manipal  Obg and Gyn OPD,Women and child block,Kasturba Medical College, Madhavnagar, Manipal, Udupi-576104
Udupi
KARNATAKA 
9676219999

pratyusha19955@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Instituitional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N328||Other specified disorders of bladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Female 
Details  All women attending gynaecology OPDs in KH will be eligible to fill up a screening
questionnaire.A subset of women with stress incontinence will be further evaluated. 
 
ExclusionCriteria 
Details  1.Pregnant women symptoms of urge or mixed incontinence
2.Women with voiding difficulty
3.Women with neurogenic bladder
4.Women with symptomatic cystitis(any bladder abnormalities)
5.Women with pelvic organ prolapse or pelvic floor dysfunction(any pelvic muscle weakness)
6.Women with uncontrolled diabetes
7.Women with renal disease, psychiatric illnesses.(any kidney or neurological problems)
8.Women with other major illnesses or malignancies (any cancers or major diseases) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the subjective domain alone of SICS with the
combined( subjective and objective ) score. 
single visit(1 day) 
 
Secondary Outcome  
Outcome  TimePoints 
To access the prevalence and treatment seeking
behaviour of SUI among women who present to gynaecological OPD. 
5 days 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   10/04/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/04/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Through this study we can understand the prevalence of urinary
incontinence in our population.This study can also be used to device a
simplified grading system to assess symptom severity using subjective
domain alone.We can also objectively determine the improvement of the
patient post treatment.
 
Close