Clinical trial NCT06921915: Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women
Official title: Viewing Woman-Centered, Animated, Explainer Videos From the Confident Bladder Website to Optimize Bladder Health and Toileting Management Behaviors: A Randomized Controlled Trial in Community-Based Women at Midlife
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder, Overactive
Urinary Incontinence, Urge
Keywords: Prevention
Learning
Clinical trials, randomized
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2025-04-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In daily life, women are exposed to a wide range of challenging situations that can negatively affect toileting management and long-term bladder health. Research shows that women engage in behaviors that may lead to unfavorable consequences, such as a worrying sense of bladder urgency or an awkward moment of urine leakage. The investigators surmise that consciously or unconsciously adopted behaviors influence lifelong bladder health, toileting management, and sense of self-efficacy in this arena. Adoption of research-supported behaviors that foster bladder well-being for women is dependent on women's access to learning multiple healthy behavioral strategies.

Studies on personal woman-centered strategies for toileting management and adoption of behaviors that foster bladder health are scarce in the scientific literature. The investigators have published encouraging results of an in-person study with a clinical sample using accessible and enjoyable videos about research-based bladder health behaviors, invented by the co-investigator of this study, Janis M. Miller.

We now launch an additional study of 90 community-based women of midlife age using an online survey methodology that incorporates sending study participants to the website. The study has two main objectives:

1. To determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the Confident Bladder Behavior Questionnaire
2. To determine at post-intervention whether behavioral profiles of the respondents have significantly changed after being randomized into one of three groups: Group 1: who watch the animated explainer videos within the Confident Bladder website that are predominantly related to daytime conditions, Group 2: who watch the Confident Bladder website's animated explainer videos predominantly related to sleep/wake conditions and the additional tips and tricks section, and Group 3: controls who only receive access to the the Confident Bladder website at study's end after post-intervention assessments.

We will test the following hypothesis:

Viewing the Confident Bladder website will demonstrate an effect size at 2-weeks post intervention of greater than 0.5, as determined by comparing number and percentage of research-based behavioral strategies used by the Control group to the number and percentage of strategies used by the two intervention groups who were assigned to view different parts of the website.


Eligibility criteria: Inclusion Criteria:

* Must have a U.S. IP Address
* Must be female between age of 40 and 64
* Must be enrolled in a Study Participant Panel accessed by Qualtrics
* Must read and speak English

Exclusion Criteria:

* NonEnglish speakers/readers
* Does not consent to participate
* Does not commit to providing thoughtful and honest answers to the surveys

Primary outcomes:
measure: The Confident Bladder Behavior Questionnaire
timeFrame: All respondents complete this questionnaire during the first session and then two weeks later. Respondents in the experimental arms complete the questionnaire prior to the eLearning activity.
Secondary outcomes:
measure: Knowledge about Healthy Bladder Behaviors
timeFrame: All respondents complete this test during the first study session. Those in the experimental arms complete it after they view the website.
measure: Urinary Cues Questionnaire
timeFrame: All respondents complete this in the first study session and two weeks after the eLearning activity.. Those in the experimental arm complete the Urinary Cues Questionnaire before the eLearning activity.
measure: Self-efficacy for Performing Healthy Bladder Behaviors
timeFrame: All respondents complete this in the first study session and two weeks after the eLearning activity.. Those in the experimental arm complete the Self-efficacy Questionnaire after the eLearning activity.
measure: Evaluation of the Website and the Study
timeFrame: All respondents complete the Evaluation surveys during the first session only. Those in the Experimental groups complete the Evaluation survey after viewing the website.
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
affiliation: Teachers College Columbia Universit
name: Kathleen A O'Connell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller JM, Hawthorne KM, Park L, Tolbert M, Bies K, Garcia C, Misiunas R, Newhouse W, Smith AR. Self-Perceived Improvement in Bladder Health After Viewing a Novel Tutorial on Knack Use: A Randomized Controlled Trial Pilot Study. J Womens Health (Larchmt). 2020 Oct;29(10):1319-1327. doi: 10.1089/jwh.2018.7606. Epub 2019 Dec 3.