Impact, Feasibility, and Acceptability of Bladder Basics (Bladder Basics)

Impact, Feasibility, and Acceptability of a Digital Health Intervention for Healthy Children With Pediatric Lower Urinary Tract Symptoms (pLUTS)

PLUTS remains a common childhood condition despite effective treatment options. It is important to improve delivery of UT at the clinical level, with future studies that shift pediatric bladder health into a broader community context. This change in contextual setting and scale can impact access to care and disease incidence beyond our current treatment paradigms. Therefore, the overall objective is to measure the early impact and feasibility of a digital health intervention, Bladder Basics. To complete this aim, we will measure clinical and education outcomes pre- and post- intervention and our assessment of acceptability and feasibility will consider framework-based barriers to implementation. Since there is limited existing data with which to build a future intervention, these variables have been carefully considered based on requirements for a future school-based intervention.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: Digital Pediatric Bladder Health Patient Education Curriculum

Detailed Description

The investigators will use a longitudinal pre-post intervention study design to pilot test the acceptability, feasibility, and preliminary educational and clinical outcomes of a novel digital health intervention, Bladder Basics. The primary outcome was the feasibility of recruiting participants to complete BB, which was assessed through metrics on recruitment, engagement, and rates of post-assessment completion. Secondary outcomes included changes in bladder symptoms (both clinical and subjective improvements), bladder health knowledge, and self-efficacy, guided by social cognitive theory. For this pilot study, no control group will be offered. Benefits of this study design include simplicity and ease of administration. As this intervention is virtual, all screening, consent procedures, and study orientation will be conducted using Zoom. Target recruitment numbers will be weighted towards Q2 and Q3 when children are more likely to be in school. The intervention consists of a 7-video curriculum that can be watched on a tablet device, computer, or phone. The videos will be watched in order at the family's convenience within a 4-week period.

Families can pause and restart the course at any time. Their learning progress will be automatically saved and synced across different devices by the online learning platform. The intervention includes 10 activities that include matching, labeling, and revealing hidden information concepts.

Timed surveys with automatic reminders will be administered and stored via a REDCap database. Pre-intervention surveys will be collected prior to obtaining access to the course and will include baseline demographics, knowledge, DVSS, and self-efficacy measures. After watching each lesson, participants will fill out a post-lesson survey to assess their ability to meet the educational objectives which will count as our short-term knowledge measure. After watching the entire course, participants will have up to 4 weeks from the start of the course to complete the first post-intervention survey. This will include a repeat measure of DVSS and self-efficacy, as well as a new assessment of acceptability, education design, and open-ended feedback questions on perceived structural barriers to adopting bladder health practices and areas for program improvement. A second post-intervention survey will be distributed at 3-months from the start of the course (long-term), and will include a repeat measure of DVSS and knowledge of bladder health practices. The time difference in measuring educational and clinical outcomes reflect the theory that the investigators would expect some degree of time to transpire between knowledge acquisition and repeated practices leading to subjective improvement. Screening, consent, study orientation procedures, and RedCap database management will be managed by a research assistant consistent with prior studies. The investigator will conduct the descriptive and quantitative data analysis portion of the study. Quantitative analysis will be performed using SPSS. The primary investigator will lead overall study completion and address any study-related obstacles or concerns. Alternative approaches include qualitative analysis of open-ended feedback questions using an iterative team-based approach to thematic analysis with myself, 1 research assistant, and 1 medical student who have both been previously trained in this method.

Expected outcomes: The investigators hypothesize that this study will demonstrate that Bladder Basics is a feasible and acceptable program for families facing pLUTS. The investigators expect robust study recruitment based on prior community interest and studies. Information obtained for this study will be used to 1) improve our existing intervention to help families awaiting pLUTS care and 2) design a school-based intervention. Data from this proposal will be submitted for presentation at academic conferences and to relevant journals for manuscript publication.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parents or guardians >= 18 years of age
• involved in the care of a child 5-10 years old with bladder problems
• English speaking

Exclusion Criteria:

• Individuals <18 years old.
• Does not meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single arm longitudinal assessment; Single arm longitudinal assessment of the feasibility of a digital pediatric bladder health patient education curriculum. The intervention consists of 7 videos that can be viewed over a 4-week time period. Impact on the study objectives will be measured using a longitudinal pre-post intervention study design.

Other: Digital Pediatric Bladder Health Patient Education Curriculum; Bladder Basics is designed to be a digital health intervention to improve knowledge of healthy bladder practices. It is a video-based bladder health curriculum based on 1) principles of Urotherapy 2) stakeholder need for a gold-standard resource 3) behavioral change theory 4) education design standards for inclusion as a comprehensive school health program (CSHP). The overall mission of the course is to teach children and their families about pediatric bladder health. The development of the course has followed the NIH's Clear & Simple standards for patient education. The 7 video lesson plan spans 60 minutes total. The course is designed to support families awaiting medical care, which would provide the continued support. In addition, one lesson shares solutions to common home and school-based barriers to behavioral change. The 4 healthy bladder practices that are promoted are- 1) pee every 3 hours 2) drinking water 3) daily poop without straining 4) toilet postures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Participants Recruited	Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.	3 months
Engagement: Video Completion Rate	Engagement was measured by assessing the video completion rate (videos watched/total videos) as calculated by the video platform.	3 months
Post-assessment Completion Rates	Post-assessment completion was measured as the percentage of participants who completed surveys following the Bladder Basics videos. After completing the videos, participants completed surveys to test knowledge, and collect data regarding user feedback and symptom improvement. The 2 post-intervention surveys were sent at 4-weeks and 12-weeks post-baseline.	4-weeks and 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes	To evaluate the impact of Bladder Basics on short- and long-term bladder health clinical outcomes by comparing baseline and post-intervention Dysfunctional Voiding Symptom Score (DVSS) questionnaire results in healthy children ages 5-10 years old with pediatric lower urinary tract symptoms. The survey consists of 10 questions, each scored from 0 to 3 (0 = Almost Never; 1 = Less Than Half the Time; 2 = About Half the Time; 3 = Almost Every Time). Scores were summed to create the overall score (0 to 30). Children with a higher DVSS score have more frequent symptoms and/or behavioral problems	baseline, 4-weeks; 12-weeks
Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam	To evaluate the impact of Bladder Basics on improving knowledge of pediatric bladder health practices by comparing baseline pre-intervention to post-intervention survey results in parents of healthy children ages 5-10 years old with pediatric lower urinary tract symptoms. Knowledge surveys will be created by study team. The survey consists of 11 questions. Correct answers are scored as 1, incorrect answers are scored as 0. Question scores were summed to create an overall score of 0 to 11, with higher scores corresponding to better knowledge about bladder health.	Baseline, Post-lesson (approximately 4 weeks) and 12 weeks post-intervention
Validated Self-efficacy Survey	To measure the acceptability and feasibility of the Bladder Basics education program. The self-efficacy survey is adapted from Parents Patient Activation Measure-13 (PPAM-13). Participants answered questions as strongly disagree, disagree, agree, strongly agree, and NA. Raw scores were transformed to an overall scale of 0 to 100. Higher scores indicate higher levels of self-efficacy.	Baseline and 4 weeks
Validated Acceptability Survey	To measure the acceptability and feasibility of the Bladder Basics education program. The acceptability survey is developed based on the Technology Acceptance Theory. The survey contains 13 questions assessing perceived usefulness, perceived ease of use, attitude towards intervention, and behavioral intention for future use. Each question is assessed on a 5-point Likert scale, each with a range from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and averaged to create the overall score, with a range of 1 to 5 (higher scores indicate better acceptability).	Immediately after completing the videos (up to 4 weeks following baseline)
Validated Education Design Survey -- Parents	To measure the acceptability and feasibility of the Bladder Basics education program. This survey is adapted from the Attention, Relevance, Confidence, and Satisfaction (ARCS) questionnaire. Each question is scored on a 5-point Likert scale ranging from 1 (not true) to 5 (very true). Scores are summed and averaged to create overall score (range: 1 to 5). Higher scores indicate better education design.	Immediately after completing the videos (up to 4 weeks following baseline)
Validated Education Design Survey - Children	To measure the acceptability and feasibility of the Bladder Basics education program. This survey is adapted from the Attention, Relevance, Confidence, and Satisfaction (ARCS) questionnaire. Each question is scored on a 5-point Likert scale ranging from 1 (not true) to 5 (very true).	Immediately after completing the videos (up to 4 weeks following baseline)
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program	Number of excerpted items obtained from participant feedback according to topic area. To measure acceptability and feasibility of Bladder Basics with consideration of stakeholder, educational design, and behavioral change theory barriers. Open-ended feedback questions were used to characterize the intervention's ability to be used as a population-level intervention. Feedback was coded according to topic area.	Immediately after completing the videos (up to 4 weeks following baseline)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kathleen Kan, MD, Stanford University

Publications and helpful links

General Publications

• Liu C, Chu J, Hughes T, Follis C, Kan KM. Empowering Bladder Health Education for Children: Integrating Situated Learning Theory and the ARCS Model in Online Program Design. J Pediatr Health Care. 2025 Oct 9:S0891-5245(25)00267-6. doi: 10.1016/j.pedhc.2025.09.005. Online ahead of print.
• Liu C, Chu J, Kan KM. Effectiveness of an Online Health Education Program for Pediatric Lower Urinary Tract Symptoms. Urology. 2025 Oct;204:171-178. doi: 10.1016/j.urology.2025.05.058. Epub 2025 May 31.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Actual): November 10, 2024
• Study Completion (Actual): November 10, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior
• Other Study ID Numbers: 67807; K12DK137162 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No