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Improving Overactive Bladder Treatment Access and Adherence

Primary Purpose

Overactive Bladder Syndrome, Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Engagement Tool
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Stanford Pelvic Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Engagement Tool (PET)

Usual Care

Arm Description

Participants will use the PET weekly for 12 weeks

Usual Clinic Follow up every 6 weeks for 12 weeks

Outcomes

Primary Outcome Measures

Usability and Engagement
Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
OAB knowledge
Knowledge regarding OAB condition and therapy

Secondary Outcome Measures

Therapy adherence
OAB management satisfaction
Change in symptom severity
Patient centeredness
Patient Global Impression of Improvement (PGI-I)
PGI-I

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT06094543
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient Engagement Tool (PET)
Arm Type
Experimental
Arm Description
Participants will use the PET weekly for 12 weeks
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Clinic Follow up every 6 weeks for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Patient Engagement Tool
Intervention Description
8 week daily patient education and engagement tool
Primary Outcome Measure Information:
Title
Usability and Engagement
Description
Usability, engagement, Patient engagement tool reliability/accessibility (technical issues)
Time Frame
12 weeks
Title
OAB knowledge
Description
Knowledge regarding OAB condition and therapy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Therapy adherence
Time Frame
12 weeks
Title
OAB management satisfaction
Time Frame
12 weeks
Title
Change in symptom severity
Time Frame
12 weeks
Title
Patient centeredness
Time Frame
12 weeks
Title
Patient Global Impression of Improvement (PGI-I)
Description
PGI-I
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Stanford Pelvic Health Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekene Enemchukwu, MD, MPH
Phone
650-723-1867
Email
oab.matters@stanford.edu
First Name & Middle Initial & Last Name & Degree
Kristine Talavera
Phone
650-723-1867
Email
oab.matters@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Overactive Bladder Treatment Access and Adherence

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