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Tailored Online Continence Promotion for Incontinence (TOCP Trial)
N/A
Waitlist Available
Led By Heidi W Brown, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
50 years or older
Must not have
Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional
Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 12, and 24 weeks
Awards & highlights
Summary
This trial will test a new online continence intervention to see if it increases engagement and uptake of health behaviors known to improve bladder and bowel symptoms.
Who is the study for?
This trial is for English-reading and writing women, aged 50 or older, who can use email and have internet access. It's not suitable for those with recent unexamined hematuria or bloody stools, dementia, or certain neurologic/musculoskeletal conditions.
What is being tested?
The study compares two online continence programs: one personalized (tailored) to the user and another without personalization. The goal is to see if tailoring improves engagement and health behaviors for bladder/bowel symptoms.
What are the potential side effects?
Since this trial involves an educational program rather than medication, traditional side effects are not expected. However, participants may experience discomfort from increased awareness of their condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Select...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had blood in my urine or stools in the past 6 months without a doctor's evaluation.
Select...
I have a condition that makes pelvic floor exercises harmful for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4, 12, and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 12, and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
User engagement with online MOM
Secondary study objectives
Change in patient estimated percent improvement (EPI)
Change in response on global perception of improvement (GPI)
Change in the response of Global patient satisfaction question (PSQ)
+10 moreOther study objectives
Program use metrics
Body Weight Changes
Self-reported behavior changes: change in fiber intake
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Online continence promotion program with tailoringExperimental Treatment1 Intervention
Participants will be allocated to the online continence promotion program with tailoring.
Group II: Online continence promotion program without tailoringActive Control1 Intervention
Participants will be allocated to the online continence promotion program without tailoring.
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,446 Total Patients Enrolled
8 Trials studying Urinary Incontinence
3,369 Patients Enrolled for Urinary Incontinence
University of Wisconsin, MadisonLead Sponsor
1,210 Previous Clinical Trials
3,157,294 Total Patients Enrolled
7 Trials studying Urinary Incontinence
976 Patients Enrolled for Urinary Incontinence
Heidi W Brown, MDPrincipal InvestigatorUW-Madison Obstetrics and Gynecology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had blood in my urine or stools in the past 6 months without a doctor's evaluation.I am 50 years old or older.I have a condition that makes pelvic floor exercises harmful for me.You have dementia.I am female.
Research Study Groups:
This trial has the following groups:- Group 1: Online continence promotion program without tailoring
- Group 2: Online continence promotion program with tailoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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