| CTRI Number |
CTRI/2024/02/063285 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identifying the type of urinary dribbling with symptoms without examination |
|
Scientific Title of Study
|
Decoding urinary incontinence with an algorithm |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRSamyuktha |
| Designation |
junior resident |
| Affiliation |
Kasturba medical college |
| Address |
Department of OBGYN
Kasturba medical college Madhav nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6382781184 |
| Fax |
|
| Email |
samyuktharavichandran1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Rajeshwari G Bhat |
| Designation |
Additional Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of OBGYN
Kasturba medical college Madhav nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448624379 |
| Fax |
|
| Email |
bhat.rajeshwari@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR Rajeshwari G Bhat |
| Designation |
Additional Professor |
| Affiliation |
Kasturba medical college |
| Address |
Department of OBGYN
Kasturba medical college Madhav nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448624379 |
| Fax |
|
| Email |
bhat.rajeshwari@manipal.edu |
|
|
Source of Monetary or Material Support
|
| kasturba medical college Manipal
Opposite Tiger circle
Manipal 576104
udupi district
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Samyuktha |
kasturba medical college manipal |
Department of Obstetrics and Gynaecology
Udupi
KARNATAKA |
6382781184
samyuktharavichandran1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N811||Cystocele, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
women willing to participate
women compliant for follow up after 3 months
women presenting to the opd with complaints of urinary incontinence for the first time |
|
| ExclusionCriteria |
| Details |
women not willing to participate
women non compliant for follow up
women presenting to the opd with already diagnosed or treated urinary incontinence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
its a simple and doable algorithm
It gives a workable and specific diagnosis before examination and investigation as it is history based
change in the quality of life after 3 months on the basis of evaluation and management for tentative diagnosis as per proposed algorithm |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
15/03/2024 |
| 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="2"
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
|
To Women presenting in the OPD with urinary incontinence for the very first time detailed description of study procedure will be given and willing participants will be recruited after Informed written consent .Simple history and symptom based questions will be asked in a stepwise manner,which has focussed questions like whether its continuous,intermittent,or any preceding event/insult,whether is able to evacuate completely from time to time.Symptoms of exclusion will also be asked to rule out specific type of incontinence. After arriving at a diagnosis ,recruited patients baseline quality of life assessment will be done using the king’s health questionnaire which has domains like general health perceptions incontinence impact,role limitations,physical limitations,social limitations,personal relationships,emotions,sleep/energy and severity of symptoms and scoring will be given. |