RECRUITING

Improving Overactive Bladder Treatment Access and Adherence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06094543

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female aged 18 years or older
  2. * OAB symptoms for at least 3 months
  3. * English/Spanish language skills and cognitive status sufficient to complete all study related materials
  4. * Behavioral treatment naïve patients
  5. * Previously treated OAB patients without supervised pelvic floor physical therapy or pharmacotherapy within 1 year
  1. * Post void residual urine \> 150ml
  2. * Confirmed diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
  3. * Pregnant or breastfeeding patients
  4. * Patients residing in a nursing home
  5. * 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)
  6. * Stage 2 or greater pelvic organ prolapse
  7. * Any history of urethral stricture
  8. * Any history of pelvic irradiation
  9. * Any history of bladder malignancy
  10. * Current symptomatic urinary tract infection (UTI), unresolved by the time of enrollment
  11. * Hematuria without a clinical evaluation
  12. * History or current use of indwelling urinary foley catheterization, suprapubic tube or intermittent catheterization
  13. * Patients with UI treated with onabotulinumtoxinA, sacral neuromodulation, or percutaneous tibial nerve stimulation (third line therapies)

Contacts and Locations

Study Locations (Sites)

Stanford Pelvic Health Center
Redwood City, California, 94062
United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Overactive Bladder Syndrome
  • Urinary Incontinence