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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new patient engagement tool designed to help women with overactive bladder (OAB) manage their condition more effectively. OAB can lead to sudden urges to urinate, frequent bathroom trips, and even accidents, making daily life challenging. The study compares usual care with the use of this tool to determine if it improves patient adherence to treatment plans. Women who have experienced OAB symptoms for at least three months and haven't tried behavioral treatments may be suitable candidates for this trial. As an unphased study, this trial allows participants to contribute to innovative research that could enhance OAB management for many women.

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.

What prior data suggests that this patient engagement tool is safe for overactive bladder patients?

Research has shown that tools like the Patient Engagement Tool (PET) help patients manage their overactive bladder (OAB) treatment more effectively. Specific data on the safety of this tool is limited because it does not involve medication or surgery.

The PET aims to assist patients in understanding and adhering to their treatment plans through education and support. As it is neither a drug nor an invasive device, it does not present typical side effects or safety issues associated with medications or surgeries.

Overall, patient engagement tools have shown promise in helping individuals adhere to their treatments without impacting their physical health, making them generally easy for participants to use. For any concerns, discussing them with the study team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Patient Engagement Tool (PET) for overactive bladder because it focuses on enhancing patient involvement in their own care, which is different from traditional approaches like medications or physical therapies. Unlike treatments that rely on pharmaceuticals to manage symptoms, this tool empowers patients by providing them with weekly interactive guidance and support over 12 weeks. This method has the potential to improve adherence to treatment plans and encourage lifestyle changes, leading to better management of symptoms without the side effects associated with medication.

What evidence suggests that this patient engagement tool is effective for overactive bladder?

This trial will compare the effectiveness of a Patient Engagement Tool (PET) with usual care for individuals with overactive bladder (OAB). Research has shown that a patient engagement tool can help people adhere to their OAB treatments. This tool educates individuals about their condition and treatment options, making it easier to follow treatment plans. Studies have found that when patients understand their condition better, they are more likely to continue their treatments. This tool addresses common issues like cost, side effects, and unrealistic expectations, which often lead to treatment discontinuation. By using technology to collect patient feedback, the tool aids doctors and patients in making better decisions together, potentially improving the success of OAB treatments. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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

Pregnant or breastfeeding patients

You live in a nursing home.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-urinary-bladder-overactive-11-2023-5e38c

Patient Engagement Tool for Overactive Bladder Trial Overview The study tests a patient engagement tool designed to improve access and adherence to OAB treatments. It aims to address underdiagnosis and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5140027/

A clinical perspective on electronically collecting patient ... Collecting patient-reported outcomes (PROs) can inform the treatment and management of overactive bladder (OAB). However, collecting these data at the point ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11054369/

Patient and Physician Decision-Making Dynamics in ... This study investigates patient and physician health beliefs surrounding decision-making and expectations for overactive bladder.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714416303159

Development of a predictive model for urgency urinary ... This predictive model is a tool that physicians can use when diagnosing and explaining to their patients the potential outcome of using fesoterodine to manage ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S240545692030300X

A Potential Alternative to the Standard Bladder Diary for ... The majority of participants were women (72.4%) with moderate OAB symptom severity (53.5%). More than one-third of participants (34.1%) were incontinent.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6824512/

Characterizing the Health-Related Quality of Life Burden ... The objective was to identify the most commonly used patient-reported outcome (PRO) instruments for overactive bladder (OAB), ...

7. medinform.jmir.org medinform.jmir.org/2022/3/e33250/

Electronic Health Record–Triggered Research Infrastructure ... The aim of this study is to develop an innovative research infrastructure that combines information from EHRs with patient experiences reported in ...