Patient Engagement Tool for Overactive Bladder

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neurological conditions, Pelvic organ prolapse, Bladder malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Overactive bladder (OAB) and urinary incontinence (UI) are chronic debilitating and embarrassing conditions that affect 33 million Americans. Yet, both are underdiagnosed and undertreated with significant financial and health-related consequences. OAB syndrome is characterized by urinary urgency, with and without urinary incontinence, urinary frequency, and nocturia. Evidence-based treatments are available, including behavioral therapy, pharmacotherapy, and minimally invasive procedures. Diagnosis and treatment are also associated with improvement in urinary symptoms and overall quality of life (QOL).3 However, 70-80% of treated patients will discontinue use of therapy in the first year due to one of several factors (e.g., cost, tolerability, inadequate effect). In addition, only 4.7% progress to advanced therapies suggesting undertreatment for those that need it most. Vulnerable populations are especially at risk, as therapy utilization are lowest among older, lower income, and/or minority groups. Poor access, insufficient patient education regarding disease chronicity, expected outcomes, costs, and potential side effects lead to unrealistic patient perceptions about therapy. This leads to suboptimal therapy duration, poor treatment efficacy, adherence, and undertreatment. The study aims to evaluate a tailored patient-centered tool to begin the treatment process.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been treated with certain advanced therapies like onabotulinumtoxinA, sacral neuromodulation, or percutaneous tibial nerve stimulation, you may not be eligible to participate.

Is the Patient Engagement Tool (Myrbetriq) safe for humans?

Mirabegron, also known as Myrbetriq, has been studied in several trials for overactive bladder and is generally considered safe for humans. It is a type of medication called a β3-adrenoceptor agonist, and while it can help with bladder symptoms, like any medication, it may have side effects, so it's important to discuss these with your doctor. ^{1 2 3 4 5}

How does the Patient Engagement Tool for Overactive Bladder differ from other treatments?

The Patient Engagement Tool for Overactive Bladder is unique because it focuses on enhancing patient involvement and satisfaction through digital technology, similar to tools used in other conditions like tuberculosis and diabetes, which aim to improve adherence and self-care through reminders and support. ^{6 7 8 9 10}

Eligibility Criteria

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.

Inclusion Criteria

English/Spanish language skills and cognitive status sufficient to complete all study related materials

I am a woman aged 18 or older.

Patients who have not previously received behavioral treatment.

Exclusion Criteria

You have more than 150ml of urine left in your bladder after you pee.

Pregnant or breastfeeding patients

You live in a nursing home.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or use the Patient Engagement Tool (PET) weekly for 12 weeks

12 weeks

Usual Clinic Follow up every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Patient Engagement Tool

Trial Overview 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.

Participant Groups

Group I: Patient Engagement Tool (PET) Experimental Treatment 1 Intervention

Participants will use the PET weekly for 12 weeks

Group II: Usual Care Active Control 1 Intervention

Usual Clinic Follow up every 6 weeks for 12 weeks

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 1060 Colombian individuals, the prevalence of overactive bladder (OAB) was found to be 31.70%, with a higher occurrence in women (39.25%) compared to men (24.15%).

Despite the high prevalence, many participants did not find their symptoms bothersome, indicating that the perceived impact on quality of life (QoL) may be less severe than the prevalence suggests, particularly as 75.6% reported no significant problems related to their bladder condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the real burden of the overactive bladder? Results from a national prevalence study. Santander, J., Plata, M., Zuluaga, L., et al.[2022]

In a 12-week study, solifenacin significantly improved patient-reported outcomes (PROs) for individuals with overactive bladder (OAB), particularly for those whose most bothersome symptom (MBS) was urge urinary incontinence (UUI).

Participants reported the greatest improvements in their symptoms and quality of life, with the UUI subgroup experiencing the most substantial benefits across various measures, including visual analog scales (VAS) and the OAB questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Sand, PK., Steers, WD., Dmochowski, R., et al.[2021]

A new patient-reported bladder assessment tool (BAT) was developed through interviews with 30 subjects, focusing on key symptoms of overactive bladder (OAB) such as nocturia, urgency, and incontinence, which were reported by all participants.

The BAT includes 17 items across four domains (symptom frequency, symptom bother, impacts, and satisfaction with treatment) and aims to provide a more comprehensive and validated method for monitoring OAB symptoms compared to traditional bladder diaries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an overactive bladder assessment tool (BAT): A potential improvement to the standard bladder diary. Kelleher, C., Chapple, C., Johnson, N., et al.[2019]

In a pooled analysis of three Phase III trials involving mirabegron 50 mg for overactive bladder, the treatment showed significant improvements in both objective measures (like incontinence and micturition frequency) and patient-reported outcomes, indicating its efficacy.

The study found strong correlations between objective improvements and patient perceptions of bladder condition, suggesting that the benefits of mirabegron translate into meaningful enhancements in quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials. Castro-Diaz, D., Chapple, CR., Hakimi, Z., et al.[2019]

In a study of 30 over-active bladder patients, adding low-dose antimuscarinic therapy (propiverine HCl, 10 mg) after 4 weeks of mirabegron (50 mg) significantly improved patient-reported outcomes, with the patient perception of bladder condition score decreasing from 4.3 to 3.2.

The add-on therapy also led to reductions in urinary frequency, urgency episodes, and urgency incontinence, with no serious side effects reported, indicating both efficacy and safety of the treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional low-dose antimuscarinics can improve overactive bladder symptoms in patients with suboptimal response to beta 3 agonist monotherapy. Shin, JH., Kim, A., Choo, MS.[2018]

In a study involving 109 patients with tuberculosis, those using the evriMED500® digital medication event reminder and monitor (MERM) reported significantly higher treatment satisfaction scores compared to those receiving standard in-person treatment, particularly in effectiveness, convenience, and overall satisfaction.

The MERM device demonstrated excellent usability, with 90.4% of users likely to recommend it, indicating that digital health innovations could enhance patient-centered care in high tuberculosis burden countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported usability and satisfaction with electronic medication event reminder and monitor device for tuberculosis: a multicentre, randomised controlled trial. Manyazewal, T., Woldeamanuel, Y., Getinet, T., et al.[2023]

The FAMS mHealth intervention, designed for disadvantaged adults with type 2 diabetes, effectively increased self-care and improved communication about diabetes between patients and their support persons, based on feedback from 19 participants over a two-week period.

FAMS is a usable and feasible tool that helps patients identify and address family actions that either support or hinder their diabetes self-care, although some participants may not have a support person to engage with.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Design, Usability, and Feasibility of a Family-Focused Diabetes Self-Care Support mHealth Intervention for Diverse, Low-Income Adults with Type 2 Diabetes. Mayberry, LS., Berg, CA., Harper, KJ., et al.[2023]

Patients in surgical oncology express a strong need for better educational resources, indicating a gap in perioperative information.

Both patients and providers support the use of a mobile application to enhance patient education, although providers initially see patient onboarding as a potential burden; however, they believe it could ultimately streamline workflows and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perceptions on utilizing a mobile technology platform to improve surgical outcomes in the perioperative setting. Huynh, B., Barrett, J., Joachim, A., et al.[2021]

A1Control, a simulation platform for insulin pump education, received a very high Net Promoter Score (9.5) and Systems Usability Scale score (mean 88.5), indicating strong usability and acceptability among rural adult insulin pump users with type 1 diabetes.

Predictors of successful performance in simulations included high continuous glucose monitoring wear time and specific bolus scores, suggesting that certain user characteristics can enhance the effectiveness of the educational tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation Platform Development for Diabetes and Technology Self-Management. Faulds, ER., Rayo, M., Lewis, C., et al.[2022]

A review of 12 clinical trials on interactive behavioral technology (IBT) for diabetes self-management showed that while these interventions were often used in primary care and targeted under-represented patients, only modest improvements in blood glucose control (A1c) were observed in 40% of the studies, with improvements ranging from -0.18% to 0.4%.

Despite some positive patient-reported outcomes and reduced healthcare utilization in several studies, the lack of incorporation of behavioral theories in most interventions and weak psychometric attention suggests a need for future research to enhance patient motivation and integrate IBT into routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive behavioral technologies and diabetes self-management support: recent research findings from clinical trials. Welch, G., Shayne, R.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

What is the real burden of the overactive bladder? Results from a national prevalence study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Development of an overactive bladder assessment tool (BAT): A potential improvement to the standard bladder diary. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Additional low-dose antimuscarinics can improve overactive bladder symptoms in patients with suboptimal response to beta 3 agonist monotherapy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Patient-reported usability and satisfaction with electronic medication event reminder and monitor device for tuberculosis: a multicentre, randomised controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The Design, Usability, and Feasibility of a Family-Focused Diabetes Self-Care Support mHealth Intervention for Diverse, Low-Income Adults with Type 2 Diabetes. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Patient and provider perceptions on utilizing a mobile technology platform to improve surgical outcomes in the perioperative setting. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Simulation Platform Development for Diabetes and Technology Self-Management. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Interactive behavioral technologies and diabetes self-management support: recent research findings from clinical trials. [2019]