School-Based Bladder Health Intervention

Not Applicable

Withdrawn

• Conditions: Urinary Tract Infections in Children; Urinary Tract Infections; Urinary Dysfunction; Lower Urinary Tract Symptoms
• Interventions: Behavioral: Bladder Health Education

• Registration Number: NCT06273098
• Lead Sponsor: Stanford University

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.

Detailed Description

In order to promote healthy bladder behaviors among school children, we will conduct a randomized control trial in schools. The research team will provide support for 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).

The study will involve 4-8 fourth grade classrooms within 2 elementary schools that meet the historical criteria for \>50% students receiving free school lunch.

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Study Start: 2028-01-01
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 4th grade students from elementary schools that meet the historical criteria for >50% students receiving free school lunch.

Exclusion Criteria

• Not meet the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder Health Education	Bladder Health Education	Participants in this arm will receive the intervention

Primary Outcome Measures

Name	Time	Method
Bathroom use	4 years	Individual child's bathroom use (# of bathroom trips measured using mobile technology bathroom passes)
Symptom score	4 years	Changes in a child's symptom score (survey questions before, during and after the study)
Urine volume	4 years	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)

Trial Locations

Locations (1)

Stanford Hospital and Clinics; 🇺🇸 Palo Alto, California, United States