Impact, Feasibility, and Acceptability of Bladder Basics

NCT05852353 | Completed Results

• 2 other identifiers: 67807K12DK137162
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes

  baseline, 4-weeks; 12-weeks

• Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam

  Baseline, Post-lesson (approximately 4 weeks) and 12 weeks post-intervention

• Validated Self-efficacy Survey

  Baseline and 4 weeks

• Validated Acceptability Survey

  Immediately after completing the videos (up to 4 weeks following baseline)

• Validated Education Design Survey -- Parents

  Immediately after completing the videos (up to 4 weeks following baseline)

Study Arms (1)

Single arm longitudinal assessment

EXPERIMENTAL

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

Interventions

Digital Pediatric Bladder Health Patient Education Curriculum OTHER

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.

Single arm longitudinal assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Individuals \<18 years old.

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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. 2026 Jan-Feb;40(1):112-127. doi: 10.1016/j.pedhc.2025.09.005. Epub 2025 Oct 9.

  PMID: 41065601 RESULT

• 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.

  PMID: 40456454 RESULT

MeSH Terms

Conditions

Behavior

Results Point of Contact

• Title: Kathleen Kan, MD
• Organization: Stanford University

kkan@stanford.edu

(650) 497-8000

Study Officials

• Kathleen Kan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL ASSISTANT PROFESSOR, UROLOGY

Model Details: Single Group Longitudinal Study looking at pre- and post- results of the same group of patients.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 10, 2023
• Study Start: August 22, 2023
• Primary Completion: November 10, 2024
• Study Completion: November 10, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)