| CTRI Number |
CTRI/2019/04/018579 [Registered on: 12/04/2019] Trial Registered Prospectively |
| Last Modified On: |
22/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Uroflometry in females - pre and post menopausal |
|
Scientific Title of Study
|
To evaluate incidence of Urinary Tract Diseases in pre and post menopausal females through Uroflowmetry test: a Prospective, Observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samir Shah |
| Designation |
HOD |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR |
| Address |
Head of Department,
Department of General Surgery,
Govt medical college,Sir T hospital, Bhavnagar
Head of Department,
Department of General Surgery,
Govt medical college,Sir T hospital, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9769105409 |
| Fax |
|
| Email |
shah.samir@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rijuta Aphale |
| Designation |
Doctor |
| Affiliation |
govt medical college, Bhavnagar |
| Address |
c 203, Sarovar Darshan towers, chandanwadi, panchpakhadi thane west
c 203, Sarovar Darshan towers, chandanwadi, panchpakhadi thane west
Thane
MAHARASHTRA
400601
India |
| Phone |
9769105409 |
| Fax |
|
| Email |
rijuta.aphale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rijuta Aphale |
| Designation |
Doctor |
| Affiliation |
govt medical college, Bhavnagar |
| Address |
c 203, Sarovar Darshan towers, chandanwadi, panchpakhadi thane west
c 203, Sarovar Darshan towers, chandanwadi, panchpakhadi thane west
Thane
MAHARASHTRA
400601
India |
| Phone |
9769105409 |
| Fax |
|
| Email |
rijuta.aphale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government medical college bhavnagar |
| Address |
Government medical college, Bhavnagar, jail road, Bhavnagar |
| Type of Sponsor |
Government medical college |
|
|
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 Samir Shah |
Sir T hospital bhavnagar |
Government medical college, surgery department, Jail road, Bhavnagar
Bhavnagar
GUJARAT |
9769105409
shah.samir@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
all pre and post menopausal women randomised into trial |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All females IPD/OPD willing to undergo in both age groups, pre and post menopausal in surgery department |
|
| ExclusionCriteria |
| Details |
pregnancy, patients not giving consent, no full bladder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| detect various urinary tract diseases diagnosed on basis of uroflowmetry graph in females of pre and post menopausal age group and compare. |
Patient assessed on immediate basis on basis of their graph |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To treat the urinary tract diseases more prevalent amongst pre and post menopausal females |
6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/04/2019 |
| Date of Study Completion (India) |
10/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study analyses the history and clinical characteristic of pre and post menopausal patients with or without voiding difficulty to diagnose various voiding problems and urinary difficulties in them. It is a non invasive primary screening method for diagnosing urinary disorders and those that prevail more commonly and pre and post menopausal women |