Trial Outcomes & Findings for Impact, Feasibility, and Acceptability of Bladder Basics (NCT NCT05852353)

Last Updated: 2025-12-19

Results Overview

Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.

Recruitment status

COMPLETED

Study phase

Target enrollment

204 participants

Primary outcome timeframe

3 months

Results posted on

2025-12-19

Participant Flow

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.

268 families met eligibility criteria. 15 families submitted surveys the were found to be fraudulent. 102 families signed informed consent and were assigned to the study arm.

Participant milestones

Participant milestones
Measure	Single Arm Longitudinal Assessment Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Overall Study STARTED	102
Overall Study Signed informed consent (child with LUTS)	72
Overall Study Signed informed consent (child did not have LUTS)	30
Overall Study Completed intervention (child with LUTS)	52
Overall Study Completed intervention (child did not have LUTS)	23
Overall Study Completed 4-week survey (child with LUTS)	51
Overall Study Completed 4-week survey (child did not have LUTS)	23
Overall Study Completed 12-week survey (child with LUTS)	47
Overall Study Completed 12-week survey (child did not have LUTS)	21
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Longitudinal Assessment Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Overall Study Family (dyad with LUTS) who consented but withdrew	2
Overall Study Family (dyad did not have LUTS) who consented but withdrew	1
Overall Study Family (dyad) who consented but did not complete intervention	24
Overall Study Family (dyad) who completed intervention but was lost to follow-up	7

Baseline Characteristics

Impact, Feasibility, and Acceptability of Bladder Basics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parent-Child Dyad - Parent Participants n=70 Participants Each parent-child dyad receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.	Parent-Child Dyad - Child Participants n=70 Participants Each parent-child dyad receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=8 Participants	70 Participants n=6 Participants	70 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=8 Participants	0 Participants n=6 Participants	70 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Sex: Female, Male Female	64 Participants n=8 Participants	47 Participants n=6 Participants	111 Participants n=6 Participants
Sex: Female, Male Male	6 Participants n=8 Participants	23 Participants n=6 Participants	29 Participants n=6 Participants
Race/Ethnicity, Customized White or European, not Hispanic or Latino	33 Participants n=8 Participants	37 Participants n=6 Participants	70 Participants n=6 Participants
Race/Ethnicity, Customized Asian or Asian American, not Hispanic or Latino	27 Participants n=8 Participants	21 Participants n=6 Participants	48 Participants n=6 Participants
Race/Ethnicity, Customized Hispanic or Latino/a	8 Participants n=8 Participants	7 Participants n=6 Participants	15 Participants n=6 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=8 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Black or African American, not Hispanic or Latino	1 Participants n=8 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized Middle Eastern or North African	1 Participants n=8 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized Other	0 Participants n=8 Participants	2 Participants n=6 Participants	2 Participants n=6 Participants
Region of Enrollment United States	70 Participants n=8 Participants	70 Participants n=6 Participants	140 Participants n=6 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Parent-child dyads who completed the screening survey.

Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=429 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Number and Percentage of Participants Recruited Expressed Interest (submitted survey) - all dyads	429 Participants
Number and Percentage of Participants Recruited Eligible for Participation - dyads with LUTS at baseline	183 Participants
Number and Percentage of Participants Recruited Consented - dyads with LUTS at baseline, excludes withdrawn dyads	70 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Parent-child dyads who signed informed consent, did not withdraw, 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)

Engagement was measured by assessing the video completion rate (videos watched/total videos) as calculated by the video platform.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=70 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Engagement: Video Completion Rate Completed 80% - 100% of the curriculum	50 Participants
Engagement: Video Completion Rate Completed 20% - 80% of the curriculum	2 Participants
Engagement: Video Completion Rate Completed 0% - 20% of the curriculum	18 Participants

PRIMARY outcome

Timeframe: 4-weeks and 12-weeks

Population: Parent-child dyads who completed the Bladder Basics video (based on parent's self-report) and completed initial post-lesson survey, 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)

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.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=52 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Post-assessment Completion Rates Completed 12-week survey	47 Participants
Post-assessment Completion Rates Completed 4-week survey	51 Participants

SECONDARY outcome

Timeframe: baseline, 4-weeks; 12-weeks

Population: Children with LUTS at baseline and who completed the 4-week and 12-week surveys, respectively.

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

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=51 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes baseline score - 4-week survey completers (both genders)	11.51 score on a scale Standard Deviation 3.12
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes 4-weeks score - 4-week survey completers (both genders)	8.47 score on a scale Standard Deviation 4.61
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes baseline score - 4-week survey completers (girls)	11.38 score on a scale Standard Deviation 3.41
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes baseline score - 4-week survey completers (boys)	11.86 score on a scale Standard Deviation 2.25
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes 4-weeks score - 4-week survey completers (boys)	8.93 score on a scale Standard Deviation 5.34
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes baseline score - 12-week survey completers (both genders)	11.53 score on a scale Standard Deviation 3.17
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes 12-weeks score - 12-week survey completers (both genders)	6.62 score on a scale Standard Deviation 3.87
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes 12-weeks score - 12-week survey completers (girls)	6.80 score on a scale Standard Deviation 3.95
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes baseline score - 12-week survey completers (boys)	11.92 score on a scale Standard Deviation 2.35
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes 12-weeks score - 12-week survey completers (boys)	6.08 score on a scale Standard Deviation 3.73
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes 4-weeks score - 4-week survey completers (girls)	8.30 score on a scale Standard Deviation 4.37
Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes baseline score - 12-week survey completers (girls)	11.40 score on a scale Standard Deviation 3.43

SECONDARY outcome

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

Population: Parents of children with LUTS at baseline and who completed immediate post-video survey and 12-week survey, respectively.

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.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=52 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam Baseline - post-lesson survey completers	10 score on a scale Interval 9.0 to 11.0
Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam Baseline - 12-week survey completers	10 score on a scale Interval 9.0 to 11.0
Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam Post-lesson score - post-lesson survey completers	11 score on a scale Interval 10.25 to 11.0
Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam 12-week score - 12-week survey completers	11 score on a scale Interval 11.0 to 11.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Parents of children with LUTS at baseline and who completed the baseline and 4-week surveys.

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.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=51 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Validated Self-efficacy Survey Baseline	63.12 score on a scale Standard Deviation 16.82
Validated Self-efficacy Survey 4-weeks	70.84 score on a scale Standard Deviation 17.16

SECONDARY outcome

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

Population: Parents of children with LUTS at baseline who completed the intervention.

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).

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=52 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Validated Acceptability Survey	4.306 score on a scale Standard Deviation 0.490

SECONDARY outcome

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

Population: Parents of children with LUTS at baseline who completed the intervention.

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.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=52 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Validated Education Design Survey -- Parents	4.31 score on a scale Standard Deviation 0.49

SECONDARY outcome

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

Population: Children with LUTS at baseline who completed the intervention.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=52 Participants Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Validated Education Design Survey - Children Fun · Strongly disagree	1 Participants
Validated Education Design Survey - Children Fun · Disagree	1 Participants
Validated Education Design Survey - Children Fun · Neither agree or disagree	4 Participants
Validated Education Design Survey - Children Fun · Agree	15 Participants
Validated Education Design Survey - Children Fun · Strongly agree	31 Participants
Validated Education Design Survey - Children Important · Strongly disagree	1 Participants
Validated Education Design Survey - Children Important · Disagree	1 Participants
Validated Education Design Survey - Children Important · Neither agree or disagree	2 Participants
Validated Education Design Survey - Children Important · Agree	12 Participants
Validated Education Design Survey - Children Important · Strongly agree	36 Participants
Validated Education Design Survey - Children Easy · Strongly disagree	0 Participants
Validated Education Design Survey - Children Easy · Disagree	1 Participants
Validated Education Design Survey - Children Easy · Neither agree or disagree	7 Participants
Validated Education Design Survey - Children Easy · Agree	20 Participants
Validated Education Design Survey - Children Easy · Strongly agree	24 Participants
Validated Education Design Survey - Children Enjoyable · Strongly disagree	3 Participants
Validated Education Design Survey - Children Enjoyable · Disagree	1 Participants
Validated Education Design Survey - Children Enjoyable · Neither agree or disagree	2 Participants
Validated Education Design Survey - Children Enjoyable · Agree	16 Participants
Validated Education Design Survey - Children Enjoyable · Strongly agree	30 Participants

SECONDARY outcome

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

Population: The Overall Number of Participants Analyzed represents the number of parent-child dyads who completed the Bladder Basics video (based on parent's self-report) and who completed initial post-intervention survey, 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).

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.

Outcome measures

Outcome measures
Measure	Parent-Child Dyad n=312 Excerpts Each family (parent-child dyad) receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks.
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Affective attitude	48 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Age appropriateness	10 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Burden	90 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Course content: Educational topics	15 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Course content: Presentation format	43 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Future content: Epidemiology of pediatric bladder health	3 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Future content: Bathroom use best practices	8 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Future content: Bathroom pathology content	28 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Future content: Dietary Information and Bowel habits	9 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Future content: Format suggestions	10 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Future content: No changes needed	24 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program General acceptability	6 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Intervention coherence	6 Excerpts
Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program Perceived effectiveness	12 Excerpts

Adverse Events

Parent-Child Dyad - Parent Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Parent-Child Dyad - Child Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Kan, MD

Stanford University

Phone: (650) 497-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place