| CTRI Number |
CTRI/2025/08/092652 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective, Within-subject comparison |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Prospective Observational Study in Patients with Lower Urinary Tract Symptoms to Compare the Effectiveness of Electronic and Paper-Based Bladder Diaries for Clinical Assessment |
|
Scientific Title of Study
|
A single centre, Prospective, observational study to evaluate the effectiveness of electronic versus paper-based bladder diaries in the clinical assessment of lower urinary tract symptoms. |
| 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 AjayKumar Gajengi |
| Designation |
Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Hospital and Research Institute
OPD No. 8, Department of Urology, Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.
Mumbai
MAHARASHTRA
401107
India |
| Phone |
9867975935 |
| Fax |
|
| Email |
drgajengiajay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AjayKumar Gajengi |
| Designation |
Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Hospital and Research Institute
OPD No. 8, Department of Urology, Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.
Mumbai
MAHARASHTRA
401107
India |
| Phone |
9867975935 |
| Fax |
|
| Email |
drgajengiajay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AjayKumar Gajengi |
| Designation |
Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Hospital and Research Institute
OPD No. 8, Department of Urology, Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.
Mumbai
MAHARASHTRA
401107
India |
| Phone |
9867975935 |
| Fax |
|
| Email |
drgajengiajay@gmail.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 Hospital and
Research Institute, 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 AjayKumar Gajengi |
Bhaktivedanta Hospital and Research Institute |
Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107
Thane
MAHARASHTRA |
9867975935
drgajengiajay@gmail.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: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 18 years with documented LUTS.
2.Owns and can operate a smartphone (for EBD arm).
3.Able to read/write in the study language.
4.Giving consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Cognitive impairment prevents diary use.
2.Inability to use mobile devices (if assigned to EBD).
3.Illiteracy (if assigned to PBD only).
4.Not giving consent to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will be to determine whether electronic bladder diaries improve user compliance, data completeness, and clinical utility compared to traditional paper-based diaries in the assessment of lower urinary tract symptoms. |
At Day 02, Day 04 and Day 05 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of fully completed diary fields per day.
2. Number of missing or inconsistent entries in each diary format to evaluate data quality.
3. Patient satisfaction & preference assessed using a 5-point Likert scale questionnaire.
4. Usability scores derived from participant responses regarding ease of use, clarity, & overall experience with each diary type.
5. Time required by clinicians to review & summarize data from each diary format.
6. Data accuracy & reliability, based on logical consistency, physiological plausibility, & timestamp verification.
7. Participant adherence over the four-day period, comparing consistency in diary completion between formats.
|
At Day 02, Day 04 & Day 05 |
|
|
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)
|
19/08/2025 |
| 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
|
This study aims to compare electronic bladder diaries (EBD) and paper bladder diaries (PBD) in assessing lower urinary tract symptoms (LUTS). The primary objective is to evaluate the feasibility, user compliance, data completeness, and overall satisfaction of EBDs versus PBDs. Secondary objectives include comparing data accuracy, clinician ease-of-use, and patient preference between the two formats. This single-center, prospective, observational study will enroll participants aged 18 or older, with documented LUTS, who can use a smartphone and read/write in the study language. Over a period of four days, participants will complete both EBD and PBD, and data on voiding patterns, fluid intake, urgency, incontinence, and nocturia will be collected. The study will measure compliance, data quality, and user satisfaction to determine if EBD offers superior benefits in clinical utility compared to traditional PBDs |