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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Engagement Tool (PET) | Experimental | Participants will use the PET weekly for 12 weeks |
|
| Usual Care | No Intervention | Usual Clinic Follow up every 6 weeks for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Engagement Tool | Behavioral | 8 week daily patient education and engagement tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systems Usability Scale (SUS) | Usability, engagement, Patient engagement tool reliability/accessibility (technical issues) | 12 weeks |
| Bladder Health Knowledge, Attitudes, and Beliefs (KAB) | Will assess knowledge about bladder health
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy adherence | 12 weeks | |
| Global Perceptions and Satisfaction with Treatment (LURN) | OAB management satisfaction | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Pelvic Health Center | Recruiting | Redwood City | California | 94062 | United States |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ICIQ-UI & ICIQ-OAB Combined Questionnaire |
Will be used to assess change in symptom severity from baseline, 4 weeks and at 12 weeks |
| 12 weeks |
| Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS) | A validated patient-reported outcome measure developed by the NIH PROMIS initiative. The Self-Efficacy for Managing Chronic Conditions - Managing Symptoms subdomain was modified to assess a patient's confidence in their ability to monitor and manage bothersome symptoms related to chronic urinary incontinence and overactive bladder (OAB). It evaluates perceived ability to recognize symptom triggers, implement behavioral or lifestyle adjustments, and manage urinary urgency, frequency, or leakage in daily life. Higher scores indicate stronger self-efficacy, which has been associated with better adherence to treatment strategies, such as bladder training, fluid management, and pelvic floor exercises, in patients with OAB and incontinence. Each item is scored on a 5-point Likert scale with higher scores indicating greater self-efficacy. It is widely used in both clinical and research settings to assess readiness for self-management and tailor interventions accordingly. | 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |