Health TrialsbyHealthPanel

Improving Overactive Bladder Treatment Access and Adherence

ConditionsOveractive Bladder SyndromeUrinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female aged 18 years or older

OAB symptoms for at least 3 months

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

Behavioral treatment naïve patients

Disqualifiers

Post void residual urine > 150ml

Confirmed diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

Pregnant or breastfeeding patients

Patients residing in a nursing home

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient Engagement Tool

    Behavioral

    8 week daily patient education and engagement tool

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Patient Engagement Tool (PET)Experimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Systems Usability Scale (SUS)

Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)

Time frame
12 weeks
2

Bladder Health Knowledge, Attitudes, and Beliefs (KAB)

Will assess knowledge about bladder health 1. Knowledge: Awareness and understanding of normal bladder function, signs and symptoms of dysfunction (e.g., incontinence, urgency), and available treatment or prevention strategies. 2. Attitudes: Perceptions and feelings toward bladder health, such as embarrassment, stigma, or normalization of symptoms like leakage or urgency. 3. Beliefs: Individual or cultural beliefs about the causes, severity, and treatability of bladder problems, which may influence care-seeking behavior.

Time frame
12 weeks

Secondary outcomes

1

Therapy adherence

Time frame
12 weeks
2

Global Perceptions and Satisfaction with Treatment (LURN)

OAB management satisfaction

Time frame
12 weeks
3

ICIQ-UI & ICIQ-OAB Combined Questionnaire

Will be used to assess change in symptom severity from baseline, 4 weeks and at 12 weeks

Time frame
12 weeks
4

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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