Clinical trial NCT06094543: Improving Overactive Bladder Treatment Access and Adherence
Official title: Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome
Urinary Incontinence
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-10-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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)

Primary outcomes:
measure: Systems Usability Scale (SUS)
timeFrame: 12 weeks
measure: Bladder Health Knowledge, Attitudes, and Beliefs (KAB)
timeFrame: 12 weeks
Secondary outcomes:
measure: Therapy adherence
timeFrame: 12 weeks
measure: Global Perceptions and Satisfaction with Treatment (LURN)
timeFrame: 12 weeks
measure: ICIQ-UI & ICIQ-OAB Combined Questionnaire
timeFrame: 12 weeks
measure: Self-Efficacy for Managing Chronic Conditions Questionnaire (PROMIS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Pelvic Health Center
state: California
Study officials:
References: