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NCT Number: NCT06094543

Improving Overactive Bladder Treatment Access and Adherence

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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Key information

Conditions

Overactive Bladder Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Previously treated OAB patients without supervised pelvic floor physical therapy or pharmacotherapy within 1 year

Exclusion criteria

  • 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
  • Comorbid neurological conditions, including spinal cord injury, progressive neurologic illnesses (e.g. Multiple Sclerosis, Parkinson's disease) or central nervous system disease (e.g. brain tumor, stroke)
  • Stage 2 or greater pelvic organ prolapse
  • Any history of urethral stricture
  • Any history of pelvic irradiation
  • Any history of bladder malignancy
  • Current symptomatic urinary tract infection (UTI), unresolved by the time of enrollment
  • Hematuria without a clinical evaluation
  • History or current use of indwelling urinary foley catheterization, suprapubic tube or intermittent catheterization
  • Patients with UI treated with onabotulinumtoxinA, sacral neuromodulation, or percutaneous tibial nerve stimulation (third line therapies)

Treatment and study plan

Patient Engagement Tool

Behavioral

8 week daily patient education and engagement tool

Primary outcomes

  1. Systems Usability Scale (SUS)

    Time frame: 12 weeks

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

  2. Bladder Health Knowledge, Attitudes, and Beliefs (KAB)

    Time frame: 12 weeks

    Will assess knowledge about bladder health

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

Secondary outcomes

  1. Therapy adherence

    Time frame: 12 weeks

  2. Global Perceptions and Satisfaction with Treatment (LURN)

    Time frame: 12 weeks

    OAB management satisfaction

  3. ICIQ-UI & ICIQ-OAB Combined Questionnaire

    Time frame: 12 weeks

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

  4. Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS)

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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