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Urinary Incontinence in Old AgeTOCPNCT05183217

Tailoring Online Continence Promotion

A study testing Online Continence promotion program without tailoring and Online Continence promotion program with tailoring in people with Urinary Incontinence in Old Age and Fecal Incontinence in Old Age, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms. Read more about this study

Who is it for?
Ages 50 years and older, women onlyHealthy volunteers can take part
What is being tested?
Online Continence promotion program without tailoring and Online Continence promotion program with tailoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
445 participants
Where
1 siteUnited States
Study dates
30 Nov 2023to 25 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female
  • 50 years or older
  • Can read \& write English
  • Can use email
  • Has access to an Internet-connected device to use the online program

Who cannot join

  • Dementia
  • Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated
  • Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin-Madison School of Medicine and Public Health

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Tailoring Online Continence Promotion for Women

This project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms.

Read the detailed description

The investigators will conduct a two-arm, parallel, randomized, controlled trial (RCT) comparing an online continence promotion program with standard weekly reminders (control arm) to an online continence promotion program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. Women in the treatment arm will receive tailored content and digital reminders for 24 weeks based on their individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs every 2 weeks resulting in re-tailored outputs. Participants will complete electronic surveys at enrollment, 4, 12, and 24 weeks. To contextualize the findings from all 3 aims, a subset of participants will be invited to complete semi-structured qualitative interviews about their engagement with the program, their adoption of health behaviors, and their perceived barriers to and facilitators of engagement and behavior change.

Being tested
Online Continence promotion program without tailoring, Online Continence promotion program with tailoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Continence promotion program without tailoringBehavioural

    Also called Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online without tailoring

    The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive automated weekly reminders reminding them to re-visit the program, regardless of their individual user activity.

  • Online Continence promotion program with tailoringBehavioural

    Also called Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) online with tailoring

    The online continence promotion program has five sections (Introduction, Exercise, Bladder, Bowels, Care Seeking) that build knowledge, self-efficacy, and skills to set action and coping plans relevant to a participant's symptoms. This online program is based on an in-person, small-group program that has demonstrated effectiveness to improve both urinary and bowel incontinence in women age 50 and above. Participants will receive tailored "output" (personalized cues, emphasis on relevant content, individualized and tailored reminders about their goals) based on a computer algorithm incorporating unique user "inputs" (individual factors). Inputs will be reassessed every 2 weeks for retailoring so that personalization evolves over the course of the intervention.

Study groups in NCT05183217
Study groupRoleWhat they receive
Online continence promotion program without tailoringActive comparatorParticipants will be allocated to the online continence promotion program without tailoring.
Receives: Behavioral: Online Continence promotion program without tailoring
Online continence promotion program with tailoringExperimentalParticipants will be allocated to the online continence promotion program with tailoring.
Receives: Behavioral: Online Continence promotion program with tailoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User Engagement With Online Mind Over Matter (MOM)

    Proportion of participants who engage with online MOM at least 4 times during weeks 0-4 in the group with (test) and without (control) tailoring.

    Measured: 0-4 weeks

Secondary outcomes (13)
  1. Self-reported Behavior Changes: Change in the Frequency of Pelvic Floor Muscle Exercises

    Frequency of pelvic floor muscle exercises

    Measured: Baseline, 4, 12, and 24 weeks

  2. Differences in Scores of the Geriatric Index for Urinary Incontinence (GSE-UI)

    The Geriatric Index for Urinary Incontinence (GSE-UI) is a validated and clinically responsive instrument for older women with urinary incontinence. Participants select a 0-10 score for each of the 12 items, with total scores ranging from 0-120. A higher score is indicative of a higher level of self-efficacy related to urinary incontinence.

    Measured: Baseline, 4, and 24 weeks

  3. Differences in Responses to the Generalized Self-Efficacy Scale Adapted for MOM Program

    Previously, in consultation with Dr. Ralf Schwarzer (Health Action Process Approach developer), the investigators adapted the Generalized Self Efficacy scale for behaviors related to continence promotion (such as pelvic floor muscle exercises).10-items are scored on a 4 point likert scale from 1 (not true at all) to 4 (exactly true) for a total range of scores from 10-40 where higher scores indicate higher self-efficacy.

    Measured: Baseline, 4, and 24 weeks

  4. Program Specific Health Action Process Approach Survey Responses Reported as Binary Outcomes

    Number of Participants who report high vs low risk perception, positive vs negative outcome expectations, specific intentions, action or coping plans, barriers and facilitators for health on the program-specific survey of other Health Action Process Approach components.

    Measured: Baseline, 4, and 24 weeks

  5. Differences in Scores of the Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q)

    The Barriers to Incontinence Care-Seeking Questionnaire (BICS-Q) contains 14-items framed on a 4-point Likert scale and is validated in women with urinary incontinence. Mean score will be reported, ranging from 1-4 where higher scores indicate increased barriers.

    Measured: Baseline and 24 weeks

  6. Differences in Scores of the Barriers to Care-seeking for Accidental Bowel Leakage (BCABL)

    The Barriers to Care-seeking for Accidental Bowel Leakage (BCABL) has been validated in women with bowel incontinence. BCABL contains 16 questions framed on a 4-point Likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree), for a total possible range of scores from 16-64 where higher scores indicate increased barriers.

    Measured: Baseline and 24 weeks

  7. Differences in Scores of the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI)

    ICIQ-UI is a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. It is scored on a scale from 0-21. Based on the score participant can be placed in four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21)

    Measured: Baseline, 4, 12, and 24 weeks

  8. Differences in Scores of the St. Mark's Incontinence Scale (SMIS) (Aka Vaizey)

    St. Mark's Incontinence Scale (aka Vaizey) will be used to assess the severity and the outcome of MOM intervention

    Never: no episodes in the past 4 weeks rarely: 1 episode in the past 4 weeks sometimes: > 1 episode in the past 4 weeks, but,1 a week; Weekly: 1 or more episodes a week but,1 a day Daily: 1 or more episodes a day

    Scores will be assigned for each row (Never=0, Rarely=1, Sometimes=2, Weekly=3, Daily=4 )

    Score will be added from each row. Cumulative minimum score=0 perfect continence; Cumulative maximum score will be 24= totally incontinence

    Measured: Baseline, 4, 12, and 24 weeks

  9. Differences in Scores of the Pelvic Floor Impact Questionnaire Short Form (PFIQ-7)

    The Pelvic Floor Impact Questionnaire Short Form (PFIQ-7) is a widely-used validated instrument that assesses condition-specific quality of life. Scores range from 0-300 with higher scores indicating higher symptom bother.

    Measured: Baseline, 4, 12, and 24 weeks

  10. Change in the Response of Global Patient Satisfaction Question (PSQ)

    Patient satisfaction will be measured with the question: How satisfied are you with your progress in this program? (completely, some-what, not at all)

    Measured: 4 and 24 weeks

  11. Change in Patient Estimated Percent Improvement (EPI)

    For EPI, Patients will be asked to estimate how much better they were on a scale from 0% (no better) to 100%(completely better)

    Measured: 4 and 24 weeks

  12. Change in Response on Global Perception of Improvement (GPI)

    Global perception of improvement (GPI) is a tool for Global Rating of Patient Satisfaction and Perceptions of Improvement.

    Question asked: Overall, do you feel that you are? Response can be chosen from the options: Much Better, Better, About the same, Worse, Much worse

    Measured: 4 and 24 weeks

  13. Differences in Scores of the 12-item Short Form Health Survey (SF-12)

    The 12-item Short Form Health Survey (SF-12) is a validated health-related quality of life questionnaire from which mental and physical component scores can be calculated. Scores on the PCS-12 (Physical Score): range from 23.99938 (difference from USA average: -26.00062) to 56.57706 (difference from USA average: 6.57706). Scores on the MCS-12 (Mental Score): range from 19.06444 (difference from USA average: -30.93556) to 60.75781 (difference from USA average: 10.75781). For both components, higher scores indicate better health-related quality of life.

    Measured: Baseline, 4, 12, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start30 Nov 2023
  3. Primary completion8 May 2024
  4. Study completion25 Sep 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
445 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05183217
Sponsor's protocol ID
2021-1555
Other IDs
1R01DK128349-01, A532800, Protocol Version 12/10/2021
Acronym
TOCP
Status last verified
May 2025
First submitted
20 Dec 2021
Last updated
25 May 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Online Continence promotion program without tailoring and Online Continence promotion program with tailoring in people with Urinary Incontinence in Old Age and Fecal Incontinence in Old Age, run by University of Wisconsin, Madison 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 5 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 25 May 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?

Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

User Engagement With Online Mind Over Matter (MOM) (time frame: 0-4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 May 2025.

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