Improving Overactive Bladder Treatment Access and Adherence

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06094543
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Syndrome; Urinary Incontinence	Behavioral: Patient Engagement Tool	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Overactive Bladder Treatment Access and Adherence Through Personalized Behavioral Modifications and Mobile Technology-Based Interventions
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient Engagement Tool (PET) Participants will use the PET weekly for 12 weeks	Behavioral: Patient Engagement Tool; 8 week daily patient education and engagement tool
No Intervention: Usual Care Usual Clinic Follow up every 6 weeks for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Usability and Engagement [12 weeks]

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

2. OAB knowledge [12 weeks]

   Knowledge regarding OAB condition and therapy

Secondary Outcome Measures

1. Therapy adherence [12 weeks]

2. OAB management satisfaction [12 weeks]

3. Change in symptom severity [12 weeks]

4. Patient centeredness [12 weeks]

5. Patient Global Impression of Improvement (PGI-I) [12 weeks]

   PGI-I

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Pelvic Health Center	Redwood City	California	United States	94062

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ekene Enemchukwu, Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT06094543
• Other Study ID Numbers: 72487; K23DK131315-01A1
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive

Study Results

No Results Posted as of Oct 23, 2023