| CTRI Number |
CTRI/2021/02/031457 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
22/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare The Effectiveness Of Visual Prostate Symptom Score And International Prostate Symptom Score In Patients With Lower Urinary Tract Symptoms Secondary To Benign Prostatic Hyperplasia
|
|
Scientific Title of Study
|
Comparitive Study Of Visual Prostate Symptom Score And International Prostate Symptom Score In Evaluation Of Men With Lower Urinary Tract Symptoms And Benign Prostatic Hyperplasia and its correlation with Uroflowmetry |
| Trial Acronym |
VPSS VS IPSS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RVEERAPPAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and
Research Institute Thiruporur Guduvanchery Main Road Ammapettai
Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9884680991 |
| Fax |
|
| Email |
veerakmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RVEERAPPAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and
Research Institute Thiruporur Guduvanchery Main Road Ammapettai
Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9884680991 |
| Fax |
|
| Email |
veerakmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RVEERAPPAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of Anaesthesiology Shri Sathya Sai Medical College and
Research Institute Thiruporur Guduvanchery Main Road Ammapettai
Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9884680991 |
| Fax |
|
| Email |
veerakmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sathya Sai Medical College and
Research Institute |
|
|
Primary Sponsor
|
| Name |
R VEERAPPAN |
| Address |
Department of UROLOGY Shri Sathya Sai Medical College and
Research Institute Thiruporur Guduvanchery Main Road Ammapettai
Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India
|
| Type of Sponsor |
Other [] |
|
|
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 |
| RVEERAPAN |
Shri Sathya Sai Medical College and Research Institute |
Department of UROLOGY Shri Sathya Sai Medical College and
Research Institute Thiruporur Guduvanchery Main Road Ammapettai
Nellikuppam Kancheepuram India
Kancheepuram
TAMIL NADU
603108
India
Kancheepuram
TAMIL NADU |
9884680991
veerakmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTERNATIONAL PROSTATE SYMPTOM SCORE VS VISUAL PROSTATE SYMPTOM SCORE |
QUESTIONARRIES VS PICTORIAL QUESTIONS |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Patient who are willing to participate in the study.Patients Who Are Having Lower Urinary Tract Symptoms Secondary To Benigh Prostatic Hyperplasia.Age Group – Above 40 |
|
| ExclusionCriteria |
| Details |
Patients With Uncontrolled Diabetes (Prostate-specific Antigen > 4 ng/dl).Patients With A History Of TURP and surgery for urethral or vesical calculus.Patients with chronic retention . And Patients, On Evaluation, Found To Have LUTS Due To A Cause Other Than BPH. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare The Effectiveness Of Visual Prostate Symptom Score And International Prostate Symptom Score In Patients With Lower Urinary Tract Symptoms Secondary To Benign Prostatic Hyperplasia
|
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare And Study The Effectiveness Of Visual Prostate Symptom Score And International Prostate Symptom Score with uroflowmetry variables.To asses the need for assistance in completing the scoring sheets |
18 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/02/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Lower Urinary Tract Symptoms (Luts) due To Benign Prostatic Hyperplasia (BPH) is common condition in men older than 40 years of age .The International Prostate Symptom Score (IPSS) is a useful and validated questionnaire To evaluate LUTS secondary To BPH .Most patients with a low education level are not able to answer the IPSS questionnaire correctly and may have to take assistance from the medical fraternity. Vanderwalt have developed an alternative questionnaire named “Visual Prostate Symptom Score (VPSS),†which assesses frequency,nocturia, weak Stream And Quality Of Life (Qol) By Means Of Pictograms |