| CTRI Number |
CTRI/2025/02/080815 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Comparing the Effectiveness of IPSS and VPSS, Questionnaires for Evaluating Urinary Symptoms. |
|
Scientific Title of Study
|
A prospective, observational study to compare the effectiveness of self-administered patient questionnaires, the International Prostate Symptom Score (IPSS) and the Visual Prostate Symptom Score (VPSS), in evaluating lower urinary tract symptoms in patients with benign prostatic enlargement. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sivaprasad Gourabathini |
| Designation |
Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD 09, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
8879614446 |
| Fax |
|
| Email |
drsivaprasad.g@bhaktivedantahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sivaprasad Gourabathini |
| Designation |
Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD 09, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
8879614446 |
| Fax |
|
| Email |
drsivaprasad.g@bhaktivedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivaprasad Gourabathini |
| Designation |
Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD 09, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
8879614446 |
| Fax |
|
| Email |
drsivaprasad.g@bhaktivedantahospital.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sivaprasad Gourabathini |
Bhaktivedanta Hospital and Research Institute |
OPD No. 09, first floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA |
8879614446
drsivaprasad.g@bhaktivedantahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL
|
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Male patients older than 45 years of age.
Male patients who presented to the Urology OPD with chief complaint of Lower Urinary Tract Symptoms (LUTS).
Patients giving consent for taking part in the study.
|
|
| ExclusionCriteria |
| Details |
Patients who had undergone surgical treatment due to a diagnosis of Benign Prostatic Hyperplasia.
Patients who had been receiving medical treatment with a diagnosis of Benign Prostatic Hyperplasia.
Patients with urethral stricture.
Patients with a prostate-specific antigen (PSA) level above 4 ng/dl.
Patients with systemic neurological disease.
Patients with history of pelvic radiotherapy.
Patients who had been diagnosed with Neurogenic Bladder.
Patients with Vesical calculi, Cystitis/Urinary Tract Infection, Carcinoma Bladder.
Patients who are Blind/Visually impaired.
Patients with indwelling Per urethral or Suprapubic catheters.
Patients on Diuretic therapy.
Patients with voided volume less than 150 mL.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Validation of VPSS as a simplified alternative to IPSS, focusing on its reduced number of questions and use of pictorial aids.
Development and validation of a new severity grading system for VPSS to improve its diagnostic capability in the Indian context.
Patient preference and ease of use of VPSS compared to IPSS, evaluated through feedback and completion rates.
Overall clinician efficiency improvement by utilizing VPSS in routine practice.
|
on week 24. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Benign Prostatic Hyperplasia (BPH) is a common condition in aging men,
with a global prevalence of 20–62% in men over 50 years. It leads to lower
urinary tract symptoms (LUTS) such as reduced urinary frequency, urgency,
nocturia, hesitancy, and incomplete bladder emptying, impacting quality of
life. The primary objectives of this study are to compare the diagnostic
effectiveness of the International Prostate Symptom Score (IPSS) and Visual
Prostate Symptom Score (VPSS) in evaluating LUTS, correlate these scores with
uroflowmetry results, assess the impact of education and age on their
completion, and analyze the time taken for completion. The secondary objectives
include validating VPSS as a simplified alternative to IPSS by introducing a
new severity grading system, assessing patient preferences and ease of use, and
improving clinician efficiency. The eligibility criteria include male patients
over 45 years with LUTS, while excluding those with prior BPH treatment,
neurological conditions, or other confounding urological issues. The
intervention involves non-pharmacological assessments using IPSS and VPSS
questionnaires. The rationale of the study is to evaluate VPSS as a reliable
and simpler tool, particularly for populations with low literacy, compared to
IPSS. The data collected will include education level, time taken to complete
the forms, assistance required, uroflowmetry results, and patient feedback. The
study duration is six months, with a sample size of 100 patients. The endpoints
include validation of VPSS as a simplified alternative, development of a new
severity grading system, and improved clinician efficiency in routine practice |