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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
Intervention / Comparator Agent
|
|
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. |