An interventional study of Digital Pediatric Bladder Health Patient Education Curriculum in Health Knowledge, Attitudes, Practice, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Stanford University · Not applicable, Interventional, and Other
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.
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.
370 studies on the registry are indexed under Behavior; 157 are open to participants now.
This study's enrollment of 204 is above the median of 119 across 294 interventional studies indexed under Behavior.
Browse Behavior studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Number and Percentage of Participants Recruited
Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.
Time frame: 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.
Time frame: 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.
Time frame: 4-weeks and 12-weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Immediately after completing the videos (up to 4 weeks following baseline)
Parents of children aged 5-10 years with presence of lower urinary tract symptoms (LUTS), defined as dysfunctional voiding scoring system (DVSS) score \> 6 for girls, \>9 for boys, were recruited from our pediatric urology clinic, local pediatric practices and the community. Community recruitment involved flyers posted in public libraries, community and childcare centers and community-based organizations.
| Milestone | Single Arm Longitudinal Assessment |
|---|---|
| Started | 102 |
| Signed informed consent (child with luts) | 72 |
| Signed informed consent (child did not have luts) | 30 |
| Completed intervention (child with luts) | 52 |
| Completed intervention (child did not have luts) | 23 |
| Completed 4-week survey (child with luts) | 51 |
| Completed 4-week survey (child did not have luts) | 23 |
| Completed 12-week survey (child with luts) | 47 |
| Completed 12-week survey (child did not have luts) | 21 |
| Completed | 68 |
| Not completed | 34 |
| Withdrew: Family (dyad with luts) who consented but withdrew | 2 |
| Withdrew: Family (dyad did not have luts) who consented but withdrew | 1 |
| Withdrew: Family (dyad) who consented but did not complete intervention | 24 |
| Withdrew: Family (dyad) who completed intervention but was lost to follow-up | 7 |
Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.
| Participants | Parent-Child Dyad |
|---|---|
| Expressed Interest (submitted survey) - all dyads | 429 |
| Eligible for Participation - dyads with LUTS at baseline | 183 |
| Consented - dyads with LUTS at baseline, excludes withdrawn dyads | 70 |
Engagement was measured by assessing the video completion rate (videos watched/total videos) as calculated by the video platform.
| Participants | Parent-Child Dyad |
|---|---|
| Completed 80% - 100% of the curriculum | 50 |
| Completed 20% - 80% of the curriculum | 2 |
| Completed 0% - 20% of the curriculum | 18 |
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.
| Participants | Parent-Child Dyad |
|---|---|
| Completed 4-week survey | 51 |
| Completed 12-week survey | 47 |
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
| score on a scale | Child Group |
|---|---|
| baseline score - 4-week survey completers (both genders) | 11.51 ± 3.12 |
| 4-weeks score - 4-week survey completers (both genders) | 8.47 ± 4.61 |
| baseline score - 4-week survey completers (girls) | 11.38 ± 3.41 |
| 4-weeks score - 4-week survey completers (girls) | 8.30 ± 4.37 |
| baseline score - 4-week survey completers (boys) | 11.86 ± 2.25 |
| 4-weeks score - 4-week survey completers (boys) | 8.93 ± 5.34 |
| baseline score - 12-week survey completers (both genders) | 11.53 ± 3.17 |
| 12-weeks score - 12-week survey completers (both genders) | 6.62 ± 3.87 |
| baseline score - 12-week survey completers (girls) | 11.40 ± 3.43 |
| 12-weeks score - 12-week survey completers (girls) | 6.80 ± 3.95 |
| baseline score - 12-week survey completers (boys) | 11.92 ± 2.35 |
| 12-weeks score - 12-week survey completers (boys) | 6.08 ± 3.73 |
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.
| score on a scale | Parent Group |
|---|---|
| Baseline - post-lesson survey completers | 10 (9 to 11) |
| Post-lesson score - post-lesson survey completers | 11 (10.25 to 11) |
| Baseline - 12-week survey completers | 10 (9 to 11) |
| 12-week score - 12-week survey completers | 11 (11 to 11) |
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.
| score on a scale | Parent Group |
|---|---|
| Baseline | 63.12 ± 16.82 |
| 4-weeks | 70.84 ± 17.16 |
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).
| score on a scale | Parent Group |
|---|---|
| Validated Acceptability Survey | 4.306 ± 0.490 |
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.
| score on a scale | Parent Group |
|---|---|
| Validated Education Design Survey -- Parents | 4.31 ± 0.49 |
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).
| Participants | Child Group |
|---|---|
| Fun — Strongly disagree | 1 |
| Fun — Disagree | 1 |
| Fun — Neither agree or disagree | 4 |
| Fun — Agree | 15 |
| Fun — Strongly agree | 31 |
| Important — Strongly disagree | 1 |
| Important — Disagree | 1 |
| Important — Neither agree or disagree | 2 |
| Important — Agree | 12 |
| Important — Strongly agree | 36 |
| Easy — Strongly disagree | 0 |
| Easy — Disagree | 1 |
| Easy — Neither agree or disagree | 7 |
| Easy — Agree | 20 |
| Easy — Strongly agree | 24 |
| Enjoyable — Strongly disagree | 3 |
| Enjoyable — Disagree | 1 |
| Enjoyable — Neither agree or disagree | 2 |
| Enjoyable — Agree | 16 |
| Enjoyable — Strongly agree | 30 |
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.
| Excerpts | Parent-Child Dyad |
|---|---|
| Affective attitude | 48 |
| Age appropriateness | 10 |
| Burden | 90 |
| Course content: Educational topics | 15 |
| Course content: Presentation format | 43 |
| Future content: Epidemiology of pediatric bladder health | 3 |
| Future content: Bathroom use best practices | 8 |
| Future content: Bathroom pathology content | 28 |
| Future content: Dietary Information and Bowel habits | 9 |
| Future content: Format suggestions | 10 |
| Future content: No changes needed | 24 |
| General acceptability | 6 |
| Intervention coherence | 6 |
| Perceived effectiveness | 12 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parent-Child Dyad - Parent Participants | 0/102 (0%) | 0/102 (0%) | 0/102 (0%) |
| Parent-Child Dyad - Child Participants | 0/102 (0%) | 0/102 (0%) | 0/102 (0%) |
Participants who completed the intervention, and in which the child in the dyad had presence of lower urinary tract symptoms at baseline (DVSS score \> 6 in girls, \> 9 in boys)
| Age, Categorical(Participants) | Parent-Child Dyad - Parent Participants | Parent-Child Dyad - Child Participants | Total |
|---|---|---|---|
| <=18 years | 0 | 70 | 70 |
| Between 18 and 65 years | 70 | 0 | 70 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Parent-Child Dyad - Parent Participants | Parent-Child Dyad - Child Participants | Total |
|---|---|---|---|
| Female | 64 | 47 | 111 |
| Male | 6 | 23 | 29 |
| Race/Ethnicity, Customized(Participants) | Parent-Child Dyad - Parent Participants | Parent-Child Dyad - Child Participants | Total |
|---|---|---|---|
| White or European, not Hispanic or Latino | 33 | 37 | 70 |
| Asian or Asian American, not Hispanic or Latino | 27 | 21 | 48 |
| Hispanic or Latino/a | 8 | 7 | 15 |
| American Indian or Alaska Native | 0 | 1 | 1 |
| Black or African American, not Hispanic or Latino | 1 | 1 | 2 |
| Middle Eastern or North African | 1 | 1 | 2 |
| Other | 0 | 2 | 2 |
| Region of Enrollment(Participants) | Parent-Child Dyad - Parent Participants | Parent-Child Dyad - Child Participants | Total |
|---|---|---|---|
| United States | 70 | 70 | 140 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stanford University