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

NCT06921915 | Completed

• 1 other identifier: 24-305
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Keywords

Prevention; Learning; Clinical trials, randomized

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Knowledge about Healthy Bladder Behaviors

  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

  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

  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

  All respondents complete the Evaluation surveys during the first session only. Those in the Experimental groups complete the Evaluation survey after viewing the website.

Study Arms (3)

eLearning Daytime

EXPERIMENTAL

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

eLearning Sleep/Wake

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

eLearning OTHER

Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.

Also known as: eLearning Daytime

eLearning Daytime; eLearning Sleep/Wake

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kathleen O'Connell: lead
• University of Michigan: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (1)

• 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.

  PMID: 31800360 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Officials

• Kathleen A O'Connell, PhD

  Teachers College Columbia Universit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This online study administered by Qualtrics Research Services randomly allocates study participants to groups. The participants don't know which group until they are assigned after they complete surveys. The group assignments are masked for the investigators and outcomes assessor until after data collection is completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Isabel Maitland Stewart Professor of Nursing Education Emerita

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: April 10, 2025
• Study Start: August 27, 2024
• Primary Completion: September 9, 2024
• Study Completion: October 6, 2024
• Last Updated: April 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)