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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06273098
Other study ID # 73162
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2028
Est. completion date December 31, 2033

Study information

Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 31, 2033
Est. primary completion date December 31, 2033
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 10 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Bladder Health Education
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).

Locations

Country Name City State
United States Stanford Hospital and Clinics Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bathroom use Individual child's bathroom use (# of bathroom trips measured using mobile technology bathroom passes) 4 years
Primary Symptom score Changes in a child's symptom score (survey questions before, during and after the study) 4 years
Primary 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
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