NCT06273098

Brief Summary

The aim of this study is to promote healthy bladder behaviors among school children. We hypothesize that a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies can promote healthy bladder behaviors among school children.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
73mo left

Started Jan 2028

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
3.9 years until next milestone

Study Start

First participant enrolled

January 1, 2028

Expected
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

6 years

First QC Date

February 15, 2024

Last Update Submit

April 22, 2024

Conditions

Keywords

School-Based InterventionBathroom PolicyHealthy Bladder BehaviorsBladder Health Education

Outcome Measures

Primary Outcomes (3)

  • Bathroom use

    Individual child's bathroom use (# of bathroom trips measured using mobile technology bathroom passes)

    4 years

  • Symptom score

    Changes in a child's symptom score (survey questions before, during and after the study)

    4 years

  • Urine volume

    Changes in a child's volume of urine (child will void into private bathroom before and during the study to understand if their bladder are too full, no direct observation)

    4 years

Study Arms (2)

Bladder Health Education

EXPERIMENTAL

Participants in this arm will receive the intervention

Behavioral: Bladder Health Education

No Bladder Health Education

NO INTERVENTION

Participants in this arm will not receive the intervention

Interventions

This will be a combination of bladder health education and awareness events, additional resources such as a water station to support healthy bladder behaviors, and tailored changes to classroom bathroom policies that are TBD (e.g. mobile technology bathroom passes).

Bladder Health Education

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th grade students from elementary schools that meet the historical criteria for \>50% students receiving free school lunch.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary Tract Infections

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Kathleen Kan

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, Urology

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Identifiers might be removed from identifiable private information and, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies. Any shared data will be de-identified.

Locations