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Tailored Online Continence Promotion for Incontinence (TOCP Trial)
N/A
Waitlist Available
Led By Megan Piper, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 12, and 24 weeks
Awards & highlights
TOCP Trial 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.Check my eligibility
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.See study design
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.
TOCP Trial 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.
TOCP Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
User engagement with online MOM
Secondary outcome measures
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 outcome measures
Program use metrics
Body Weight Changes
Self-reported behavior changes: change in fiber intake
+4 moreTOCP Trial 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.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,798 Total Patients Enrolled
8 Trials studying Urinary Incontinence
3,369 Patients Enrolled for Urinary Incontinence
University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,144 Total Patients Enrolled
7 Trials studying Urinary Incontinence
976 Patients Enrolled for Urinary Incontinence
Megan Piper, PhDPrincipal InvestigatorUniversity of Wisconsin Dept of Medicine
1 Previous Clinical Trials
623 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial still accepting new participants?
"As evidenced by the details displayed on clinicaltrials.gov, this trial has concluded its patient recruitment and is no longer accepting applicants. Initially posted on January 1st 2023, with its last update occuring in late September 2022, it stands alongside 169 other active trials looking for participants right now."
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