Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Intervention / Treatment: Other: eLearning

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Teachers College, Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eLearning Daytime; This group completes pre-intervention surveys and then is assigned to view the part of the website that deals with Daytime Hold Confidence. Participants engage in an elearning activity on how to prevent and deal with urinary urges during daytime activities. Participants in the group complete post-intervention surveys immediately after viewing the website and two weeks after study entry.	Other: eLearning; Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.; Other Names: eLearning Daytime
Experimental: eLearning Sleep/Wake; This group completes pre-intervention surveys and then is assigned to view the part of the website that deals with Sleep/Wake Confidence. Participants engage in an elearning activity on how to prevent and deal with urinary urges that occur after the participant has fallen asleep and then when they arise in the morning. In addition, this group is assigned to the Tips and Tricks, which covers additional information. Participants in the group complete post-intervention surveys immediately after viewing the website and two weeks after study entry.	Other: eLearning; Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.; Other Names: eLearning Daytime
No Intervention: Control Group; This group completes pre-intervention surveys and then immediately completes the post-intervention surveys. Two weeks after study entry they complete the same surveys completed by members of the other two groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Confident Bladder Behavior Questionnaire	A 31-item questionnaire assessing the extent to which respondents engage in behaviors related to maintaining a healthy bladder.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about Healthy Bladder Behaviors	A 14-item multiple choice test on the information conveyed in the website.	All respondents complete this test during the first study session. Those in the experimental arms complete it after they view the website.
Urinary Cues Questionnaire	A 21-item survey assessing the extent to which participants recognize that each cue gives them the urge to urinate.	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.
Self-efficacy for Performing Healthy Bladder Behaviors	a 12-item survey assessing the respondents' confidence that they can carry out healthy bladder behaviors.	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.
Evaluation of the Website and the Study	For Experimental groups, a 14-item questionnaire assessing the respondents' experience with the website and their intention to follow the advice offered by the website. For Control Group, a 4-item questionnaire assessing the respondents' experience with the study and their intention to view the Confident Bladder website after the study.	All respondents complete the Evaluation surveys during the first session only. Those in the Experimental groups complete the Evaluation survey after viewing the website.

Collaborators and Investigators

• Sponsor: Kathleen O'Connell
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Kathleen A O'Connell, PhD, Teachers College Columbia Universit

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): October 6, 2024

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Learning; Clinical trials, randomized
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: 24-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No