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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

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/092652
Enrollment
100
Registered
2025-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: X- New Technology

Interventions

Intervention1: Nil: Nil Intervention2: NIL: NIL Intervention3: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: At Day 02, Day 04 and Day 05—

Secondary

MeasureTime frame
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. Timepoint: At Day 02, Day 04 & Day 05—

Countries

India

Contacts

Public ContactDr AjayKumar Gajengi

Bhaktivedanta Hospital and Research Institute

drgajengiajay@gmail.com9867975935

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026