Improving Overactive Bladder Treatment Access and Adherence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094543
• Other study ID #: 72487
• Secondary ID: K23DK131315-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Behavioral:
• Patient Engagement Tool
8 week daily patient education and engagement tool

Locations

Country	Name	City	State
United States	Stanford Pelvic Health Center	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability and Engagement	Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)	12 weeks
Primary	OAB knowledge	Knowledge regarding OAB condition and therapy	12 weeks
Secondary	Therapy adherence		12 weeks
Secondary	OAB management satisfaction		12 weeks
Secondary	Change in symptom severity		12 weeks
Secondary	Patient centeredness		12 weeks
Secondary	Patient Global Impression of Improvement (PGI-I)	PGI-I	12 weeks