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Patient Engagement Tool for Overactive Bladder
N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female aged 18 years or older
OAB symptoms for at least 3 months
Must not have
Confirmed diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
Stage 2 or greater pelvic organ prolapse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is researching how to better diagnose and treat OAB/UI, which affect 33 million Americans. The goal is to improve patient symptoms & QOL and reduce undertreatment, especially in vulnerable populations.
Who is the study for?
This trial is for women over 18 with overactive bladder (OAB) symptoms for at least 3 months, who can understand English or Spanish. They should not have had certain treatments in the past year and must be new to behavioral treatment. Excluded are those with specific medical conditions like severe bladder issues, neurological diseases, or a history of pelvic radiation.
What is being tested?
The study tests a patient engagement tool designed to improve access and adherence to OAB treatments. It aims to address underdiagnosis and undertreatment by providing tailored education on disease management, expected outcomes, costs, and side effects.
What are the potential side effects?
Since this trial focuses on a patient engagement tool rather than medication or invasive procedures, traditional side effects are not applicable. However, there may be indirect consequences related to changes in how patients manage their OAB treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 or older.
Select...
I have had overactive bladder symptoms for at least 3 months.
Select...
I have OAB and haven't had specific therapy or medication for it in the last year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Interstitial Cystitis or Painful Bladder Syndrome.
Select...
My pelvic organ prolapse is at stage 2 or higher.
Select...
I have a history of urethral stricture.
Select...
I have had radiation treatment to my pelvic area.
Select...
I have a history of bladder cancer.
Select...
I currently have a UTI that hasn't improved.
Select...
I have a neurological condition like MS, Parkinson's, a brain tumor, or have had a stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
OAB knowledge
Usability and Engagement
Secondary study objectives
Patient Global Impression of Improvement (PGI-I)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Engagement Tool (PET)Experimental Treatment1 Intervention
Participants will use the PET weekly for 12 weeks
Group II: Usual CareActive Control1 Intervention
Usual Clinic Follow up every 6 weeks for 12 weeks
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,423 Total Patients Enrolled
8 Trials studying Urinary Incontinence
3,784 Patients Enrolled for Urinary Incontinence
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,182 Total Patients Enrolled
4 Trials studying Urinary Incontinence
636 Patients Enrolled for Urinary Incontinence