Urinary Bladder, OveractiveNCT06921915
Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women
A study testing eLearning in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Kathleen O'Connell at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
- What is being tested?
- eLearning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2024to 6 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- NonEnglish speakers/readers
- Does not consent to participate
- Does not commit to providing thoughtful and honest answers to the surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Teachers College, Columbia University
New York, New York, 10027
About this study
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
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.
Read more
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:
- To determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the Confident Bladder Behavior Questionnaire
- 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.
- Being tested
- eLearning
- Keywords
- Prevention, Learning, Clinical trials, randomized
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eLearningOther
Also called eLearning Daytime
Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Confident Bladder Behavior Questionnaire
A 31-item questionnaire assessing the extent to which respondents engage in behaviors related to maintaining a healthy bladder.
Measured: 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
A 14-item multiple choice test on the information conveyed in the website.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: All respondents complete the Evaluation surveys during the first session only. Those in the Experimental groups complete the Evaluation survey after viewing the website.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start27 Aug 2024
- Primary completion9 Sep 2024
- Study completion6 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen O'Connell
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor-investigator, Kathleen O'Connell, Teachers College, Columbia University
- Investigators
- Kathleen A O'Connell, PhD, Principal investigator, Teachers College Columbia Universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921915
- Sponsor's protocol ID
- 24-305
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31800360
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06921915
- Acronym / sponsor ID
- 24-305
- Keywords
- Prevention, Learning, Clinical trials, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kathleen O'ConnellUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the Confident Bladder Behavior Questionnaire
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eLearning Daytime | Experimental | Other: eLearningThis 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. |
| eLearning Sleep/Wake | Experimental | Other: eLearningThis 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. |
| 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. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- NonEnglish speakers/readers
- Does not consent to participate
- Does not commit to providing thoughtful and honest answers to the surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eLearningAlso: eLearning DaytimeParticipants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges. | Other | eLearning Daytime, eLearning Sleep/Wake |
Primary outcome
The Confident Bladder Behavior Questionnaire
Time frame: 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.
A 31-item questionnaire assessing the extent to which respondents engage in behaviors related to maintaining a healthy bladder.
4 secondary outcomes
Knowledge about Healthy Bladder Behaviors
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: All respondents complete the Evaluation surveys during the first session only. Those in the Experimental groups complete the Evaluation survey after viewing the website.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 31800360Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A O'Connell, PhD principal investigator
Teachers College Columbia Universit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eLearning in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Kathleen O'Connell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Confident Bladder Behavior Questionnaire (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.